PKG, CONNECTED OR HUB BASE SYSTEM
Report
- Report Number
- 0002936485-2023-00898
- Event Type
- Malfunction
- Date Received
- September 6, 2023
- Date of Event
- August 7, 2023
- Report Date
- July 12, 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
- FL, 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 ALLEGED FAILURE: FLICKERING 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. 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) MANUFACTURE DATE IS NOT KNOWN THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
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 LOSS OF IMAGE.
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1170787 | 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 |