NOZZLE,STRAIGHT,ABC,DISP/20

Additional Manufacturer Narrative

THE USED DEVICE WAS RETURNED TO CONMED WITHOUT ORIGINAL PRODUCT PACKAGING. UPON VISUAL INSPECTION, THE DEVICE WAS OBSERVED TO HAVE DEFORMED MOLDING AND THE NEEDLE WAS CHARRED ON THE DEVICE'S PROXIMAL END. THE DEFECT APPEARED AS IF THE PROXIMAL END OF THE NEEDLE HAD MELTED THE DEVICE'S MOLDING. WHEN THE NEEDLE WAS MORE THAN 5 MM OUT OF THE HOUSING AT THE DISTAL END, THE NEEDLE WOULD FALL OUT OF THE MOLDED HOUSING. POTENTIALLY, THE NEEDLE BECAME HOT ENOUGH TO MELT THE DEVICE MOLDING, WHICH RESTRAINED IT FROM FALLING OUT. A REVIEW OF THE MANUFACTURING DOCUMENTS VERIFIED THE DEVICE WAS PRODUCED PER CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED AT THE TIME OF MANUFACTURE. A REVIEW OF THIS LOT NUMBER, WITH (B)(4) PIECES MANUFACTURED, SHOWED NO OTHER COMPLAINTS FOR THIS LOT PRODUCT AND EVENT DESCRIPTION. (B)(4). IT IS GOOD MEDICAL PRACTICE TO INSPECT AND/OR TEST EQUIPMENT PRIOR TO USE. DUE TO THE SEVERITY OF THIS REPORTED PATIENT INJURY, AN INVESTIGATION HAS BEEN INITIATED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A RIGHT HEPATIC RESECTION, THE TIP OF THE 130343 ABC HANDPIECE CAME OFF. THIS LED TO INJURY TO THE DIAPHRAGM AND A PNEUMOTHORAX. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE AND A 15-MINUTE PROCEDURAL DELAY TO RECOVER THE ELECTRODE TIP AND REPAIR THE DIAPHRAGM. UPON GATHERING ADDITIONAL INFORMATION, THE PATIENT HAS BEEN DISCHARGED HOME AND REQUIRED ONE ADDITIONAL DAY IN THE HOSPITAL AND SPECIFIC DRUG THERAPY. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED PATIENT INJURY.