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Surgical lights fall|The manufacturer reported missing screws in the United States in December last year, and the Hospital Authority regretted that there was no notification

2023-02-21T12:50:08.227Z


In the operating room of the United Hospital last Saturday (18th), a large surgical lamp fell, and an anesthesia assistant was hit by the lamp and injured his shoulder. Checking the data, the United States recorded an adverse event report of a related brand in December last year, and Sweden’s Gen


In the operating room of the United Hospital last Saturday (18th), a large surgical lamp fell, and an anesthesia assistant was hit by the lamp and injured his shoulder.

Checking the data, the United States recorded an adverse event report of a related brand in December last year. The Swedish Gentinge manufacturer reported that the screws of the Maquet Volista supervisor disappeared, and there were no casualties. The lack of screws on the supervisor may cause the device to fall and cause damage. Serious injury was caused, so the matter was reported to the US FDA.


The Hospital Authority stated that it purchased a surgical lamp of the same model as the above-mentioned incident, which was confirmed safe after inspection and can continue to be used; this model of surgical lamp was not used in the United Christian Hospital.

The bureau criticized the contractor Gentinge for failing to report the incident and expressed regret for exposing medical staff and patients to risk.


A large surgical lamp fell in the operating room of the United Hospital last Saturday. The relevant surgical lamp is Maquet VOLISTA brand, type VOLISTA 600 STANDOP, and the contractor for the maintenance of the surgical lamp is Getinge.

Looking through the data, the U.S. Food and Drug Administration (FDA) received an adverse event report of a related brand on December 20 last year. The Swedish Gentinge manufacturer reported that the screw in charge of its Maquet Volista disappeared. Missing screws on the device may cause the device to fall and cause serious injury, so report the matter to FDA.

According to the website of the Medical Instrument Division of the Department of Health, the operating lamp is at risk level I.

The Department is required to collect and publish medical device safety warnings and special warnings reported by the industry or overseas regulatory agencies, but the relevant incidents have not been published on the website.

Peng Hongchang estimated that because the US FDA report was voluntary, it was raised to a safety alert and a special alert, and the investigation was not completed, so the Department of Health and the Hospital Authority may not be aware of the incident.

He believes that the Department should regularly review the voluntary reporting cases in various places, and consider whether to notify the Hospital Authority and other public organizations.

Review the Medical Device Administration System Local Responsible Person Medical Incident Reporting Guidelines for incidents occurring outside Hong Kong that lead to corrective or preventive action (whether voluntary by the manufacturer or required by a regulatory authority) for a listed device by the manufacturer and recall actions), the local responsible person shall notify the Medical Device Division of the relevant details and the actions to be taken in Hong Kong as soon as possible within ten calendar days after the manufacturer takes the action.

Peng Hongchang, secretary of the Hong Kong Association of Community Organizations.

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However, the surgical light in this incident is not included in the list of medical devices, and the FDA report has not yet completed the investigation, so it is impossible to judge whether the incident requires the manufacturer to take corrective or preventive actions.

Peng Hongchang said that there is a gray area in the relevant provisions, but he agrees that the factory should report the relevant situation to the Department of Health and the Hospital Authority. "Better than the Department of Health and the Hospital Authority know this information, everyone will be more careful." It is hoped that the department can strengthen communication with manufacturers after this incident, so as to avoid similar incidents from happening again.

In reply to the inquiry, the Hospital Authority stated that according to the records, the manufacturer and maintenance contractor of the surgical lights involved did not report to the Hospital Authority that it had reported to the US Food and Drug Administration that a missing screw incident occurred in one of the surgical lights , and expressed regret that the contractor did not report the safety incidents related to its products to the Bureau and disclose the relevant potential risks, which exposed medical staff and patients to risks.

The Hospital Authority added that preliminary information showed that the Hospital Authority had purchased a surgical light of the same model as the above-mentioned incident, which was confirmed to be safe after inspection and could continue to be used; this type of surgical light was not used in United Hospital.

The Hospital Authority also pointed out that it will continue to follow up the incident seriously, and has instructed the contractor to continue to inspect the surgical lights in public hospitals and submit reports on the incident, and to make appropriate and effective follow-up to prevent similar incidents from happening again.

The Hospital Authority reserves the right to pursue relevant responsibilities against the contractor.

United Hospital Surgical Light|Social Association pointed out that the United States has lost screws at the end of last year. The report urged the Hospital Authority to account for the United Hospital’s falling surgical lamp. : The siren sounded, endangering medical care and patients, and the combined hospital operating lights fell into groups. Engineering industry: Involved in a Swedish brand, the screws were easy to loose, and the combined hospital’s operating lights involved 6 screws breaking, and the same lamp was loose, causing 12 operating rooms to be out of service.

Source: hk1

All news articles on 2023-02-21

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