GRASPING FORCEPS
Received Jan 14, 2025 · Event occurred Dec 16, 2024
Report 9614641-2025-00047 · MDR key 21152725
Device
Generic name
Grasping Forceps
Manufacturer
Aomori Olympus Co., Ltd.Model number
FG-53SX-1Lot number
K4909-0549
Product problems
- Device Reprocessing Problem
- Device Reprocessing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: INSUFFICIENT LUBRICANT WAS APPLIED. 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
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN MATTER ADHESION DURING PRE-USE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.