FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED

Additional Manufacturer Narrative

THE BIOPSY FORCEPS WERE RETURNED WITH A CLEARLY DAMAGED JAW, AND A PORTION OF THE MECHANISM THAT OPENS AND CLOSES THE JAW WAS OUT OF POSITION. THE DEVICE WAS EXAMINED AND CONTAMINANTS CONSISTENT WITH EXPOSURE, IF NOT USE, WERE FOUND TO BE PRESENT. THE DEVICE WAS ABLE TO OPEN AND CLOSE WITHOUT ISSUE. THE ROOT CAUSE FOR THE DAMAGE WAS UNDETERMINED, HOWEVER, AS THE DEVICE WAS USED IN THE FIELD, THE DEVICE MAY HAVE BEEN MISHANDLED OR DAMAGED DURING ITS USE.

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A SUPPLEMENTAL FORM WILL BE SENT ONCE THE EVALUATION IS COMPLETED IF THE DEVICE IS RETURNED. THE DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS TESTED BY OPENING AND CLOSING PRIOR TO PLACING IT IN THE SCOPE. UPON OPENING, WHILE IN THE PATIENT TO RETRIEVE A BIOPSY, THE DEVICE BROKE. IT WAS NOTED THAT NO FRAGMENTS OR PIECES WERE LEFT IN THE PATIENT. IT WAS REPORTED THAT THERE WAS NO HARM DETECTED TO THE PATIENT.