InjuryOCZ
HYSAFE
Received Nov 4, 2025
Report 1418479-2025-00013 · MDR key 23468859
Device
Generic name
Grasp. Forceps Insert 5fr Wl 340mm
Manufacturer
Richard Wolf GmbhModel number
86426508Catalog number
8642.6508
Lot number
4500309024
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A HYSTEROSCOPY BIOPSY, THE HEALTHCARE PHYSICIAN WAS UNABLE TO TAKE A SAMPLE OF TISSUE OR POLYPS USING THE INSTRUMENT. THERE IS NO REPORT OF INJURY OR UNACCEPTABLE RISKS, HOWEVER THE PLANNED PROCEDURE COULD NOT BE COMPLETED SINCE THERE WAS NO BACK-UP DEVICE. LATER, THE PATIENT WAS REFERRED TO ANOTHER HEALTHCARE PHYSICIAN.