TISCHLER-MORGAN BIOPSY FORCEPS

Description of Event or Problem

THE FORCEPS LOCKED UP DURING A COLPOSCOPY PROCEDURE, AND THE PHYSICIAN WAS UNABLE TO RE-OPEN IT FOR REMOVAL FROM THE PT. THE PHYSICIAN REPORTEDLY "CUT AROUND" THE LOCKED FORCEPS HEAD IN ORDER TO REMOVE THE INSTRUMENT. THE PT EXPERIENCED LITTLE BLEEDING, DID WELL, AND WAS JUST UNCOMFORTABLE. A FIRST FOLLOW-UP EXAMINATION PERFORMED ON (B)(6), SHOWED THAT BLEEDING HAD STOPPED COMPLETELY, AND AT THE SECOND FOLLOW-UP ON (B)(6) 2009, THE PT WAS FOUND TO BE HEALING AND "OK". NO FURTHER FOLLOW-UPS WERE DEEMED NECESSARY NOR SCHEDULED BY THE TREATING PHYSICIAN. THE CUTTING EDGE OF THE BIOPSY FORCEPS WAS FOUND TO BE CORRODED, IMPAIRING THE CUTTING FUNCTION. IT IS ASSUMED THAT THE TISSUE BEING SAMPLED WAS NOT COMPLETELY AND CLEANLY CUT BY THE FORCEPS. THE TISSUE CAUGHT IN THE INSTRUMENT, CAUSING IT TO JAM DURING THE PROCEDURE.

Additional Manufacturer Narrative

(B)(4). CONCLUSION: THE ONLY POSSIBLE CAUSE IDENTIFIED FOR THE EVENT WAS THE IMPAIRMENT OF CUTTING FUNCTION PROVOKED BY MATERIAL CORROSION OF THE CUTTING EDGE. IT IS ASSUMED THAT THE TISSUE BEING SAMPLED WAS NOT COMPLETELY AND CLEANLY CUT BY THE FORCEPS DUE TO THIS CORROSION. THE TISSUE CAUGHT IN THE INSTRUMENT, CAUSING IT TO JAM DURING THE BIOPSY PROCEDURE. SUBSEQUENTLY, THE STERILIZATION PROCESS MAY HAVE SHRUNK THE TISSUE AND UNBLOCKED THE FORCEPS, WHICH WOULD EXPLAIN THAT IT WAS RETRIEVED FROM THE STERILIZATION AND DRYING PROCESS IN AN OPEN POSITION. WHEN PROPERLY CLEANED ACCORDING TO USER INSTRUCTIONS, NO MATERIAL CORROSION SHOULD OCCUR. THE TYPE OF CORROSION OBSERVED ON THE FORCEPS IS TYPICALLY PRODUCED BY USER OF AGGRESSIVE OR CAUSTIC CORROSIVE SOLUTIONS, CLEANING AGENTS OR ACIDS AND/OR BY INSUFFICIENT RINSING WITH DISTILLED WATER AFTER DISINFECTION. IN THESE CASES OF IMPROPER CLEANING AND MAINTENANCE, REMNANTS OF CORROSIVE SUBSTANCES MAY REMAIN ON THE INSTRUMENT AND CAUSE CORROSION OVER TIME. NO OTHER CAUSE FOR MALFUNCTION COULD BE IDENTIFIED. THE CORROSION ON THE INSTRUMENT WAS CLEARLY VISIBLE TO THE NAKED EYE. IF CAREFUL EXAMINATION OF THE FORCEPS CUTTING EDGE HAD TAKEN PLACE BEFORE THE PROCEDURE, AS INDICATED BY USER INSTRUCTIONS, IT IS REASONABLE TO EXPECT THAT THE CORRECTION DAMAGE SHOULD HAVE BEEN DETECTED BY THE USER.