KEY SURGICAL UNIVERSAL LIGHT HANDLE COVER

Additional Manufacturer Narrative

THE EVENT WAS REPORTED TO KEY SURGICAL BY (B)(4). THE REPORTED EVENT OCCURRED IN (B)(6); HOWEVER, KEY SURGICAL HAS HISTORICALLY MARKETED SIMILAR VERSIONS OF THE DEVICE IN THE UNITED STATES USING THE SAME PART NUMBER. THE DEVICE WAS UNAVAILABLE FOR INVESTIGATION. KEY SURGICAL, TOGETHER WITH (B)(4) REQUESTED ADDITIONAL INFORMATION FROM THE HOSPITAL FACILITY THAT INITIALLY REPORTED THE COMPLAINT INFORMATION TO THE DISTRIBUTOR, (B)(4) ON SEVERAL SEPARATE DATES. THE USER FACILITY WAS UNABLE TO PROVIDE FURTHER INFORMATION ON EVENTS LEADING UP TO THE DESCRIBED EVENT, BUT WAS ABLE TO CONFIRM PART NUMBER, LOT NUMBER AND DEVICE DESCRIPTION INFORMATION. THE CAUSE OF THE REPORTED MALFUNCTION/ADVERSE EVENT IS UNKNOWN. THE LOT HISTORY INFORMATION INCLUDING DEVICE HISTORY RECORDS, INSPECTION RECORDS AND REQUESTS FOR INFORMATION ON SUPPLIER MANUFACTURING INFORMATION FOR THE REPORTED LOT RESULTED IN NO NON-CONFORMITIES, ABNORMALITIES OR INFORMATION RELATED TO THE COMPLAINT ROOT CAUSE. THROUGH 12/12/2018, REVIEW OF COMPLAINT HISTORY AGAINST SALES DATA REVEALS THAT THE COMPLAINT RATE FOR THE LIGHT HANDLE COVER T IS (B)(4).

Description of Event or Problem

SURGICAL LIGHT HANDLE COVER PLACED OVER LIGHT HANDLE PRIOR TO SURGICAL START. INTRAOPERATIVELY, THE SURGEON REACHED FOR THE LIGHT TO CHANGE THE ANGLE. THE LIGHT HANDLE COVER SPLIT AND FELL INTO THE SURGICAL FIELD. THE USER FACILITY REPORTED THAT THE PATIENT WAS TREATED WITH ANTIBIOTICS POSTOPERATIVELY. NO OTHER PATIENT IMPACT WAS REPORTED.