FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM
Report
- Report Number
- 0002936485-2025-00174
- Event Type
- Malfunction
- Date Received
- March 5, 2025
- Date of Event
- February 6, 2025
- Report Date
- August 26, 2025
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- NBH
- UDI-DI
- 07613252633181
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
THREE ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE FOR EVALUATION, AND IT IS YET TO BE RECEIVED IN-HOUSE. NO FURTHER ATTEMPTS TO RETRIEVE THE DEVICE ARE REQUIRED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: TIP BREAKING PROBABLE ROOT CAUSE: APPLICATION - EXCESSIVE FORCE - POOR VISUALIZATION THROUGH ARTHROSCOPE THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
THE PRODUCT HAS NOW BEEN PHYSICALLY RECEIVED AT STRYKER ENDOSCOPY, USA AND THE INVESTIGATION HAS BEEN RE-OPENED. INVESTIGATION AS FOLLOWS IS NOW BASED ON PRODUCT RECEIVED. ALLEGED FAILURE: THE FLOWPORT II CANNULA (CAT 02438, LOT: 011393) BROKE OFF IN THE CAPSULE. PART OF IT FELL INTO THE ACETABULUM AND HAD TO BE RETRIEVED. TIME LOSS APPROX. 60 MIN. THE SECOND CANNULA FROM THE SAME KIT ALSO BROKE AFTER THE EXTENSION WAS COMPLETED. THE CANNULA WAS IN THE JOINT WITH THE OPTICS AND WAS SLIGHTLY CRUSHED. THE BROKEN PART ALSO HAD TO BE RETRIEVED, WHICH TOOK ANOTHER 70 MINUTES. ALL PARTS COULD BE REMOVED. THE EXTENSION TIME WAS EXTENDED BY OVER 2 HOURS, THE CONSEQUENCES FOR THE PATIENT ARE UNCLEAR. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE COULD BE USE OF EXCESSIVE FORCE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438358 | FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM | ACCESSORIES, ARTHROSCOPIC | NBH | STRYKER ENDOSCOPY-SAN JOSE | 011393 | 07613252633181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |