GRASPING FORCEPS

Description of Event or Problem

AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING AN UNKNOWN THERAPEUTIC PROCEDURE THE DEVICE JAW CAME OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT BODY. THE PROCEDURE WAS COMPLETED BY USING A SIMILAR DEVICE. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED.

Additional Manufacturer Narrative

THE DEVICE IS RETURNED BUT THE DEVICE EVALUATION IS NOT YET COMPLETED. AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. SUPPLEMENTAL REPORT(S) WILL BE FILED AS ANY RELEVANT NEW INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE PROCEDURE IS URETERAL STENT REMOVAL. THE EVENT HAPPENED WHEN OPENING THE FORCEPS. THE BROKEN PIECE OF THE FORCEPS FELL INTO THE PATIENT BLADDER. THE PIECE WAS NOT REMOVED FROM THE PATIENT BECAUSE IT WAS OF A SIZE TO PASS OUT OF THE PATIENT BODY WITH URINATION. THE PROCEDURE WAS COMPLETED WITH A SPARE FORCEPS WITH A DELAY OF FIVE TO TEN MINUTES. AN X-RAY IMAGE AFTER THE PATIENT PASSED URINE, DID NOT SHOW ANY BROKEN PIECE IN THE PATIENT.

Additional Manufacturer Narrative

THE DEVICE HAS BEEN EVALUATED. ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE DEVICE WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE DEVICE IS RETURNED AND AN EVALUATION COMPLETED FOR IT. THE USER¿S COMPLAINT WAS CONFIRMED. UPON INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT ONE OF THE ARMS OF THE CUPS (A PART OF THE LINKING MECHANISM AT THE DISTAL END) WAS BROKEN OFF. THE BROKEN ARM HAD BROWN FOREIGN MATERIAL AROUND THE BROKEN PLACE. PART OF THE BROKEN ARM WAS MISSING. PART OF THE BROKEN ARM WAS CORRODED. FROM THE INVESTIGATION RESULT, A POSSIBLE MECHANISM OF THE BREAK COULD BE AS BELOW: 1. INSUFFICIENT CLEANING OF THE DEVICE AFTER USE LEFT FOREIGN MATERIAL AND/OR DETERGENT SOLUTION ON THE ARM OF THE CUPS. 2. THE RESIDUE CORRODED THE ARM AND WEAKENED IT. 3. THE WEAKENED ARM BROKE OFF WHEN A FORCE WAS APPLIED TO IT DURING HANDLING. THE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING STATEMENTS THAT RELATE TO THE EVENT: BEFORE USE, CONFIRM THAT THE INSTRUMENT IS NOT CORRODED, DENTED OR DISCOLORED ; DO NOT USE IT IF ANY OF THESE CONDITIONS ARE OBSERVED. IF THE INSTRUMENT IS DAMAGED, PART OF IT COULD FALL OFF INSIDE THE PATIENT, OR IT COULD BECOME IMPOSSIBLE TO OPEN OR CLOSE. NEVER USE EXCESSIVE FORCE TO OPEN OR CLOSE THE GRASPING JAWS. THIS COULD DAMAGE THE INSTRUMENT. REPROCESS THE INSTRUMENT IMMEDIATELY AFTER USE, FIRST BY IMMERSING IT IN A NEUTRAL, LOW-FOAMING, MEDICAL GRADE DETERGENT SOLUTION, THEN FOLLOWING THE CLEANING AND STERILIZATION PROCEDURES GIVEN IN THIS CHAPTER. FAILURE TO REPROCESS THE INSTRUMENT IMMEDIATELY AFTER USE, OR USING OTHER THAN A MEDICAL-GRADE DETERGENT MAY CAUSE CORROSION AT THE METAL PARTS LIKE THE GRASPING JAWS. THIS COULD IMPAIR THE OPERATION OF THE INSTRUMENT OR CAUSE A PART OF IT TO BREAK AND/OR FALL OFF INSIDE THE PATIENT. ·DO NOT GRASP OBJECTS OR TISSUE WITH EXCESSIVE FORCE. THE GRASPING JAWS MAY BECOME DAMAGED AND COULD FALL OFF INSIDE THE PATIENT. CONTINUOUSLY MONITOR THE ENDOSCOPIC IMAGE DURING THE PROCEDURE, AND MAKE SURE THAT THE INSTRUMENT APPEARS AND OPERATES PROPERLY. IF A PART OF THE INSTRUMENT FALLS OFF INSIDE THE PATIENT, STOP USING IT IMMEDIATELY. USE A SPARE INSTRUMENT TO RETRIEVE THE PART.