GRASPING FORCEPS
Received Jul 8, 2026
Report 9614641-2026-00721 · MDR key 25752807
Device
Product problems
- Device Reprocessing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
RELATED PATIENT IDENTIFIER: (B)(6). B3: DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WAS UNABLE TO IDENTIFY THE REASON WHY PROPER CLEANING AND STERILIZATION WERE NOT PERFORMED. OLYMPUS CAN ASSUME THAT THE DECISION TO STERILIZE THE REUSABLE MEDICAL DEVICE (FG-45U-1) WITH STERRAD WAS MADE BY THE USER FACILITY. ALTHOUGH THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED, WE WILL CONTINUE TO MONITOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
THE CUSTOMER RETURNED THE REUSABLE TRIPOD FORCEPS THAT HAD BEEN STERAD STERILIZED DURING REPROCESSING INVOLVING THE OLYMPUS GRASPING FORCEPS. THERE WAS NO PATIENT INVOLVEMENT.