PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 70°, 140MM, SPEED-LOCK
Report
- Report Number
- 0002936485-2021-00627
- Event Type
- Injury
- Date Received
- November 11, 2021
- Date of Event
- October 15, 2021
- Report Date
- January 12, 2022
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- HRX
- UDI-DI
- 07613327416473
- PMA / PMN Number
- K183470
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. ALLEGED FAILURE: FOGGING AND CONDENSATION: PROBABLE ROOT CAUSE: LASER WELDING SEAL FAILURE, DISTAL/PROXIMAL WINDOW SOLDER FAILURE, DAMAGE TO OPTICAL TRAIN, DAMAGE TO NEEDLE, DAMAGE TO DISTAL OR PROXIMAL WINDOWS, MOISTURE INTRUSION, END OF LIFE WEAR-OUT, ENVIRONMENTAL DISTURBANCE: ENDOSCOPE COLDER THAN DEW POINT. ENVIRONMENTAL DISTURBANCE: FLUID ENTRAPMENT BETWEEN THE COUPLER AND EYEPIECE. JUNCTION (EYEPIECE ONLY). USE ERROR . THE DEVICE MANUFACTURE DATE IS NOT KNOWN. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. H3 OTHER TEXT: 81.
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO OPEN.
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1699063 | PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 70°, 140MM, SPEED-LOCK | ARTHROSCOPE | HRX | STRYKER ENDOSCOPY-SAN JOSE | 0502-404-070 | 07613327416473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |