RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
Report
- Report Number
- 9610773-2025-07843
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Date of Event
- November 14, 2025
- Report Date
- December 23, 2025
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HIH
- PMA / PMN Number
- K931995
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION TO D4 - LOT NUMBER (ADDED) AND NO SERIAL NUMBER.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D4, D10, E1 NAME AND ADDRESS, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: G4 IS K931995, H5 SHOULD BE NO. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE OF THE CERAMIC HEAD; ISSUE RELATED TO STRESS PROBLEM OR EXCESSIVE FORCE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED THE RESECTION SHEATH HEAD END WAS FRACTURED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142486 | RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS | A42011A | HIH | OLYMPUS WINTER & IBE GMBH | A42011A | 22808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |