PKG, CONNECTED OR HUB BASE SYSTEM
Report
- Report Number
- 0002936485-2023-00974
- Event Type
- Malfunction
- Date Received
- September 22, 2023
- Date of Event
- September 7, 2023
- Report Date
- July 11, 2024
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GCJ
- UDI-DI
- 07613327413281
- PMA / PMN Number
- K222079
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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: FLICKERING IMAGE PROBABLE ROOT CAUSE: ¿ CABLES, CONNECTORS, SOURCES, OR SINKS ¿ CAPTURE CARD, MOTHERBOARD, POWER SUPPLY ¿ SDC FIRMWARE ¿ OVER-HEATING (AIR DUCT, FANS, HEAT SINKS, DUST, VENTS) ¿ SDC APPLICATION SOFTWARE, CLARITY PACKAGE ¿ CLARITY ALGORITHM ¿ MANUFACTURING DEFECTS (PROCESS, WORKMANSHIP) ¿ USE ERROR ¿ CYBERSECURITY ¿ ESP SOFTWARE THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.
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.
IT WAS REPORTED THAT THERE WAS FLICKERING IMAGE.
IT WAS REPORTED THAT THERE WAS FLICKERING IMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1562076 | PKG, CONNECTED OR HUB BASE SYSTEM | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | STRYKER ENDOSCOPY-SAN JOSE | 07613327413281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |