MalfunctionPTS
GRASPING FORCEPS
Received May 22, 2026 · Event occurred Apr 1, 2026
Report 9614641-2026-00536 · MDR key 25259840
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered, Exempt
Manufacturer
Aomori Olympus Co., Ltd.Model number
FG-53SX-1Product problems
- Break
Patient
49 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE GRASPING FORCEPS WHILE ATTEMPTING TO GRASP STENT WITH ALLIGATOR GRASPER THE BOTTOM PRONG BROKE OFF. THE ISSUE OCCURRED DURING A DIAGNOSTIC LEFT URETERAL STENT REMOVAL VIA CYSTOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.