PKG CONNECTED OR HUB BASE SYSTEM
Report
- Report Number
- 0002936485-2025-00710
- Event Type
- Malfunction
- Date Received
- August 21, 2025
- Date of Event
- July 10, 2024
- Report Date
- September 11, 2025
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GCJ
- UDI-DI
- 07613327413281
- PMA / PMN Number
- K222079
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ALLEGED FAILURE: OVERHEATING. CONFIRMED FAILURE: CONFIRMED FAILURE: FLICKERING DUE TO FAULTY CAPTURE CARD. FAILURE TO REMOVE PHI/PATIENT DATA. UPGRADED SOFTWARE. SSD FAILURE. PROBABLE ROOT CAUSE: FAN(S) FAILURE. AIR DUCT FAILURE. POWER SUPPLY FAILURE. TEMPERATURE SENSOR FAILURE. FIRMWARE/SOFTWARE FAILURE - NO/INCORRECT TEMPERATURE SENSING. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
ALLEGED FAILURE: OVERHEATING CONFIRMED FAILURE: CONFIRMED FAILURE: FLICKERING DUE TO FAULTY CAPTURE CARD FAILURE TO REMOVE PHI/PATIENT DATA UPGRADED SOFTWARE SSD FAILURE PROBABLE ROOT CAUSE: ¿ FAN(S) FAILURE ¿ AIR DUCT FAILURE ¿ POWER SUPPLY FAILURE ¿ TEMPERATURE SENSOR FAILURE ¿ FIRMWARE/SOFTWARE FAILURE - NO/INCORRECT TEMPERATURE SENSING THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
IT WAS REPORTED THAT THE DEVICE OVERHEATED. THEREFORE, THERE WAS A THERMAL EVENT.
IT WAS REPORTED THAT THE DEVICE OVERHEATED. THEREFORE, THERE WAS A THERMAL EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466210 | 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 |