(B)(4). MANUFACTURING SITE EVALUATION: EIGHT SHUMACHER BIOPSY FORCEPS WE RECEIVED. ACCORDING TO THE CUSTOMER THE MOVEMENT AND THE CUTTING PERFORMANCE OF FOUR OF THE EIGHT FORCEPS IS NOT ACCORDING TO THE WARRANTED SPECIFICATIONS. INTRAOPERATIVELY A BIOPSY COULD NOT BE TAKEN OUT OF THE PATIENT WITHOUT PULLING. THIS PULLING CAUSED PAIN FOR THE PATIENT. FOUR FORCEPS OUT OF BATCH 52413302 AND FOUR OUT OF BATCH 52422427. ALL PRODUCTS ARE DECONTAMINATED AND AVAILABLE FOR INVESTIGATION. THERE IS TEMPORARY DAMAGE TO THE PATIENT THAT WILL HEAL FULLY AND WILL MOST LIKELY NOT NEGATIVELY INFLUENCE THE PATIENT IN THE FUTURE. THERE WAS A VISUAL AND A FUNCTIONAL TEST PERFORMED FOR EACH FORCEPS BY THE Q-COORDINATOR OF THE PRODUCTION PLANT. ACCORDING TO THE TEST THE CUTTING WAS PERFORMED USING THE TEST MATERIAL. TWO OF THE FOUR FORCEPS ARE CUTTING ACCORDING TO SPECIFICATIONS. THE MOVEMENT OF THE JAW IS HOOKING AND NOT SMOOTH. AT ONE FORCEPS, IT IS NOT POSSIBLE TO CLOSE THE JAW, THE BLADES ARE NOT FITTING TOGETHER. HERE TOO, BURRS ON THE MOVEABLE JAW PARTS CAN BE FOUND. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO A MANUFACTURING ERROR.
D
Patient 1
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE "ON (B)(6) (B)(6) CALLED ME. SHE IS A SPECIALIZED WARD GYNECOLOGY NURSE. SHE TOLD THE SALES REPRESENTATIVE THAT ON (B)(6) THE (GYNECOLOGIST) PERFORMED A COLPOSCOPY FOR WHICH SHE USED ARTICLE NUMBER ER064R. THE UPPER PART OF THE JAWS DID NOT FULLY CLOSE IN THE LOWER PART. THEREFORE A BIOPSY COULD NOT BE TAKEN OUT OF THE PATIENT WITHOUT PULLING IT OUT. THIS PULLING CAUSED PAIN FOR THE PATIENT." "ON (B)(6) THE (B)(6) ORDERED 8 BIOPSY FORCEPS. (ORDER#: (B)(4)) DURING THIS PROCEDURE THE DOCTOR TRIED 4 OF THE 8 FORCEPS AND SHE NOTICED THAT 4 FORCEPS DID NOT CLOSE AS THEY SHOULD. THE SALES REPRESENTATIVE PICKED UP THE 4 FORCEPS, AND THE OTHER 4 FORCEPS SEEMED TO WORK PROPERLY. FOUR FORCEPS WERE TRIED DURING SURGERY AND THE GYNECOLOGIST NOTICED THESE 4 CLOSED INSUFFICIENTLY. THE SALES REPRESENTATIVE CHECKED THE REMAINING 4 PCS AND NOTICED THAT THESE 4 ALSO CLOSE INSUFFICIENTLY." ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00383 , 9610612-2018-00382(THIS REPORT), 9610612-2018-00405, 9610612-2018-00406, 9610612-2018-00407.