MalfunctionPTS
CENTRA
Received Apr 16, 2026 · Event occurred Mar 18, 2026
Report 1528319-2026-00033 · MDR key 24899280
Device
Generic name
Biopsy Forceps
Manufacturer
Us EndoscopyModel number
00711250Catalog number
00711250
Lot number
(10)104971
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
THE CENTRA DISPOSABLE BIOPSY FORCEPS SUBJECT OF THE REPORTED EVENT IS BEING RETURNED FOR EVALUATION. INVESTIGATION OF THE EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE CENTRA DISPOSABLE BIOPSY FORCEPS CAUSED "BLEEDING" AND "TEARING". USER FACILITY PERSONNEL UTILIZED A HEMOSTASIS CLIP AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.