GRASPING FORCEPS
Received Oct 15, 2025 · Event occurred Sep 17, 2025
Report 9614641-2025-01696 · MDR key 23290604
Device
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 INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETSED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THE GRASPING FORCEPS HAD NO ULTRASONIC CLEANING PERFORMED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE MDR SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE UPDATED FIELDS AND FINAL INVESTIGATION RESULTS. UPDATED FIELDS: H2, H6, H11. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE CUSTOMER'S ALLEGATION COULD NOT BE CONFIRMED. 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 WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.