RESECTION SHEATH, 24 FR.
Report
- Report Number
- 9610773-2023-01471
- Event Type
- Malfunction
- Date Received
- May 26, 2023
- Date of Event
- May 22, 2023
- Report Date
- June 9, 2023
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HIH
- UDI-DI
- 04042761020961
- PMA / PMN Number
- K931994
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS MEDWATCH IS BEING SUPPLEMENTED WITH ADDITIONAL INFORMATION OBTAINED. MEDWATCH MFR: BELONGS TO A DUPLICATE COMPLAINT AND WILL BE CLOSED. ANY ADDITIONAL INFORMATION WILL BE SUPPLEMENTED ON MEDWATCH MW # (B)(4).
THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. DURING THE INITIAL EVALUATION, THE REPORTED ISSUE WAS CONFIRMED. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K931995.
IT WAS REPORTED TO OLYMPUS THAT A RESECTION SHEATH HAD A CERAMIC TIP THAT WAS LOOSE AND NOT DAMAGED. THE REPORTED PROBLEM WAS FOUND DURING MAINTENANCE. THERE WAS NO PROCEDURE INVOLVED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1609263 | RESECTION SHEATH, 24 FR. | SURG, NON-EN | HIH | OLYMPUS WINTER & IBE GMBH | A22041A | 17ZW-0014 | 04042761020961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |