REFLEX

Description of Event or Problem

THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 8735, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE, WAS BEING PRE-OP TESTED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿IT DIDN¿T RELEASE SO I HAD TO PLACE ANOTHER STAPLE IN ORDER FOR IT TO RELEASE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

Additional Manufacturer Narrative

THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Additional Manufacturer Narrative

RECEIVED SIX 8735 IN OPENED ORIGINAL PACKAGE. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, NO ABNORMALITIES OR DEFECTS WERE OBSERVED. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICE FUNCTIONED AS INTENDED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED REFLEX® ONE AND REFLEX® TL SKIN STAPLERS SHOULD BE USED ONLY BY PERSONNEL WITH ADEQUATE TRAINING AND KNOWLEDGE OF SKIN CLOSURE PROCEDURES. THE REFLEX® ONE AND REFLEX® TL ARE INTENDED FOR USE IN SKIN CLOSURE PROCEDURES AND ARE NOT TO BE USED ON INTERNAL TISSUE CLOSURE AS PLACEMENT AND PROXIMITY TO BONES, VESSELS, AND INTERNAL ORGANS ARE NOT VERIFIABLE. PRIOR TO INSERTING STAPLE, CONFIRM STAPLE WILL BE POSITIONED FREE OF OTHER STAPLES OR OBSTRUCTIONS. FIRING A STAPLE OVER ANOTHER STAPLE MAY RESULT IN TISSUE COMPRESSION AND RISK OF COMPROMISED HEALING OR SCARRING. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 8735, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE, WAS BEING PRE-OP TESTED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿IT DIDN¿T RELEASE SO I HAD TO PLACE ANOTHER STAPLE IN ORDER FOR IT TO RELEASE.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.