INNER SHEATH, FOR 26 FR. OUTER SHEATH
Report
- Report Number
- 9610773-2026-02260
- Event Type
- Malfunction
- Date Received
- March 25, 2026
- Report Date
- April 30, 2026
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HIH
- UDI-DI
- 04042761029339
- PMA / PMN Number
- K931995
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
SUPPLEMENTAL MDR IS BEING SUBMITTED TO PROVIDE A CORRECTION TO THE FOLLOWING FIELDS: D2A- INNER SHEATH. D4- LOT NUMBER SHOULD BE NI. D8- NO. G2- SHOULD BE USER FACILITY AND FOREIGN. G4- K931995.
IT WAS REPORTED THAT THE HYSTEROSCOPE, GYNECOLOGY, EXHIBITED TIP IS CHIPPED. THERE WERE NO REPORTS OF PATIENT HARM.
NO ADDITIONAL INFORMATION REPORTED FROM THE CUSTOMER.
SUPPLEMENTAL MDR IS BEING SUBMITTED TO PROVIDE A CORRECTION TO THE FOLLOWING FIELDS: D2A, D4, D8, G2, G4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45004 | INNER SHEATH, FOR 26 FR. OUTER SHEATH | INNER SHEATH | HIH | OLYMPUS WINTER & IBE GMBH | A22040A | NI | 04042761029339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |