inforMED
MalfunctionPTS

GRASPING FORCEPS

Received Dec 17, 2021 · Event occurred Nov 14, 2021

Report 8010047-2021-16309 · MDR key 13024056

Device

Generic name

Grasping Forceps

Model number

FG-53SX-1

Lot number

K1629-1321

Product problems

  • Break
  • Break

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS EVALUATED AND INVESTIGATED BY OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THE GRASPING JAWS REMAINED OPEN AND COULD NOT CLOSE WHEN THE SLIDER WAS OPERATED. THE OTHER ARM OF THE GRASPING JAWS (A PART OF THE LINKAGE MECHANISM AT THE DISTAL END) WAS BROKEN OFF. THE BROKEN ARM HAD BROWN FOREIGN MATERIALS AROUND THE BROKEN PLACE. THE BROKEN SURFACE INDICATED BRITTLE FRACTURE DUE TO CORROSION. THE BROKEN ARM HAD BROWN FOREIGN MATERIALS AROUND THE BROKEN PLACE. THE BROKEN ARM WAS MISSING. THERE WERE NO OTHER ABNORMALITIES THAT COULD LEAD TO THE EVENT YOU POINTED OUT. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT INDICATED NO ANOMALY WITH THE EVENT-RELATED BELLOW; OPERATION, APPEARANCE OF THE TIP. IT WAS CONCLUDED THAT THE GRASPING JAWS DOES NOT OPEN AND CLOSE BECAUSE THE LINKAGE MECHANISM WAS BROKEN. BASED ON THE INVESTIGATION RESULT, A LIKELY CAUSE OF THE BROKEN LINKAGE MECHANISM MIGHT BE THE FOLLOWING. FOREIGN MATERIALS OR CLEANING SOLUTION HAD LEFT ON THE ARM OF THE GRASPING JAWS DUE TO INSUFFICIENT CLEANING OF THE DEVICE. RESIDUES ON THE ARM OF THE GRASPING JAWS CORRODED AND DECREASED ITS STRENGTH. A FORCE WAS APPLIED TO THE LINKAGE MECHANISM WHILE HANDLING THE DEVICE. AS A RESULT, THE LINKAGE MECHANISM PART WHERE DECREASED ITS STRENGTH WAS BROKEN. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

Description of Event or Problem

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE NON-HEALTHCARE PROFESSIONAL THAT DURING AN UNSPECIFIED PROCEDURE, WHEN A SURGEON TRIED TO GRASP A STENT BY THE SUBJECT DEVICE TO CHANGE TO ANOTHER STENT, THE DISTAL END OF THE SUBJECT DEVICE WAS BROKEN. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. ON NOVEMBER 26, OMSC FOUND THAT THE OTHER ARM OF THE GRASPING JAWS (A PART OF THE LINKAGE MECHANISM AT THE DISTAL END) WAS BROKEN OFF AND THE BROKEN SURFACE INDICATED BRITTLE FRACTURE DUE TO CORROSION. ALSO, THE BROKEN ARM WAS MISSING.