GRASPING FORCEPS

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. IN THE EVALUATION OF OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) THE FOLLOWING WAS CONFIRMED, - 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. - THE GRASPING JAW WAS BROKEN AT THE BRAZING JOINT OF THE OPERATION WIRE AND GRASPING JAW. - PART OF THE BROKEN ARM WAS MISSING. - PART OF THE BROKEN ARM WAS CORRODED. THE DEVICE HISTORY RECORD (DHR) WITH THE LOT NUMBER OF THE SUBJECT DEVICE WAS CONFIRMED. NO ABNORMALITIES DETECTED IN THE DHR FOR THE FOLLOWING ITEMS WHICH RELATED TO THE REPORTED PHENOMENON. -INSPECTION OMSC ASSUMED THAT CUPS COULD NOT OPEN AND CLOSE DUE TO THE BROKEN ARM, WHICH CAUSED THE REPORTED UNAVAILABLE OF THE DEVICE FROM THE INVESTIGATION RESULT, A POSSIBLE MECHANISM OF THE BREAK IS SHOWN 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 ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

Description of Event or Problem

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE SUBJECT DEVICE BROKE AFER ONLY 6 MONTHS OF USE. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE DISTRIBUTOR CONFIRMED THE FOLLOWING EVENT ON (B)(6) 2021 AND DETERMINED THAT IT WAS AN MEDICAL DEVICE REPORT (MDR) REPORTABLE EVENT. PART OF THE BROKEN ARM WAS MISSING. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. IN THE EVALUATION OF OMSC THE FOLLOWING WAS CONFIRMED, THE MODEL NAME WAS FG-53SX-1 WITH LOT NO K05. 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. THE BROKEN SURFACE INDICATED THE BREAK WAS A BRITTLE FRACTURE CAUSED BY CORROSION. PART OF THE BROKEN ARM WAS MISSING. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.