INNER SHEATH, FOR 26 FR. OUTER SHEATH
Report
- Report Number
- 9610773-2025-05324
- Event Type
- Malfunction
- Date Received
- August 25, 2025
- Date of Event
- August 13, 2025
- Report Date
- October 3, 2025
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HIH
- UDI-DI
- 04042761029339
- PMA / PMN Number
- K931995
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELD: G4 - PMA/510(K) # K931995 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: THE MOST LIKELY CAUSE IS IMPACT, DROPPING, SHOCK OR SIMILAR STRESS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
IT WAS REPORTED THAT DURING REPROCESSING, THE SUBJECT INNER SHEATH HAD A BROKEN TIP. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2335451 | INNER SHEATH, FOR 26 FR. OUTER SHEATH | A22040A | HIH | OLYMPUS WINTER & IBE GMBH | A22040A | 04042761029339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |