MalfunctionKGE
DISPOSABLE HOT BIOPSY FORCEPS
Received May 19, 2026 · Event occurred Apr 22, 2026
Report 9614641-2026-00521 · MDR key 25224590
Device
Generic name
Disposable Hot Biopsy Forceps
Manufacturer
Aomori Olympus Co., Ltd.Model number
FD-230ULot number
NI
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THE DISPOSABLE HOT BIOPSY FORCEPS EXHIBITED A BURN MARK ON THE DISTAL END. THE ISSUE OCCURRED DURING A DIAGNOSTIC UNSPECIFIED PROCEDURE AND WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.