04-1/2 EXTRACTING FORCEPS

Additional Manufacturer Narrative

WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem

IT IS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT BROKE NEAR THE HINGE. IT IS REPORTED THE PIECES WERE RECOVERED AND NO PARTS OF THE INSTRUMENT WERE EMBEDDED IN THE PATIENT. IT IS REPORTED THE EVENT DID NOT CAUSE A DELAY OR AN INJURY TO THE PATIENT. IT IS REPORTED THE PROCEDURE WAS COMPLETED WITH ANOTHER AVAILABLE PAIR OF FORCEPS.

Additional Manufacturer Narrative

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

Additional Manufacturer Narrative

THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. VISUAL INSPECTION SHOWS MODERATE USE. THE FORCEPS ARE FRACTURED THROUGH THE DIAMETER OF THE HINGE ON ONE OF THE SHANKS OF THE FORCEPS; THEREFORE, THE COMPLAINT IS CONFIRMED. THE FRACTURE IS CONSISTENT WITH DAMAGE THAT WOULD BE CAUSED BY THE IMPACT OF DROPPING THE PART. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT IS GENERAL HANDLING DAMAGE. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT STATES IN THE SECTION TITLED WARNINGS AND PRECAUTIONS: "AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS." THE NON-CONFORMANCE DATABASE WAS REVIEWED AND NO NON-CONFORMANCE WAS FOUND FOR THIS PRODUCT. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS.