PKG, CONNECTED OR HUB BASE SYSTEM
Report
- Report Number
- 0002936485-2023-00899
- Event Type
- Injury
- Date Received
- September 6, 2023
- Date of Event
- August 8, 2023
- Report Date
- September 10, 2024
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GCJ
- UDI-DI
- 07613327413281
- PMA / PMN Number
- K222079
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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.
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. THE DEVICE WAS NOT SENT BACK TO STRYKER AND WAS INVESTIGATED ON SITE. THE ONSITE STRYKER REPRESENTATIVES ATTEMPTED TO TROUBLESHOOT THE ISSUE. IT WAS REPORTED THAT THE STRYKER REPRESENTATIVE EVALUATED THE DEVICES AND WAS ABLE TO RESEAT AND CLEAN THE VIDEO CARD AND REPLACED ONE CABLE. ON (B)(6) 2023, STRYKER REPRESENTATIVES WENT OUT TO THE SITE AND TRIED TO REPLICATE THE ISSUE BUT WERE UNSUCCESSFUL. FROM (B)(6) 2023, MEETINGS WERE HELD WITH THE STRYKER COMMUNICATIONS ENGINEERING TEAM TO DISCUSS THE DETAILS AND FINDINGS FROM THE ON-SITE INVESTIGATIONS. THE DEVICES THEN APPEARED TO BE IN GOOD WORKING CONDITION. THE ON-SITE INVESTIGATIONS INDICATED THAT THE REPORTED ISSUE OF VIDEO FLICKERING, INVOLVED THE ENDOSCOPY CAMERA SIGNAL TRAVELING THROUGH THE SPI3 ROUTER INPUT CARD TO THE SPI3 OUTPUT (VPM) CARD THROUGH THE HUB DVI INPUT AND OUTPUT BACK THROUGH THE SPI3 ROUTER INPUT CARD TO THE SPI3 OUTPUT CARD (VPM) AND REACHED THE FINAL DESTINATION AT THE TWO (2) 4K MONITORS. FURTHER TROUBLESHOOTING CONFIRMED THAT THE FLICKERING SIGNAL WAS PRESENT THROUGH THE SIGNAL PATH DESCRIBED ABOVE. WHEN THE CONNECTED OR HUB WAS BYPASSED, THE ENDOSCOPY CAMERA SIGNAL WAS ROUTED THROUGH THE SPI3 INPUT CARD TO THE SPI3 OUTPUT (VPM) CARDS TO THE DESTINATION OF THE TWO (2) 4K MONITORS, AND THE FLICKERING WAS RESOLVED. ASSUMING EQUIVALENCY FOR THE INCOMING ENDOSCOPY CAMERA SIGNAL AND SPI3 ROUTER OUTPUT (VPM) CARDS FOR EACH SCENARIO, THE CAUSE OF THE FLICKERING EVENT POINTS TO THE CONNECTED OR HUB DVI SIGNAL PATH AS THE MOST LIKELY CONTRIBUTING FACTOR. 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). THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.
IT WAS REPORTED THAT WHEN ALL THE MONITORS WERE FLICKERING, THE SURGEON PUNCTURED THE PATIENT'S BOWEL WHILE INSERTING A TROCAR AND HAD TO CONVERT TO OPEN PROCEDURE. AN ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED DUE TO THE PUNCTURED BOWEL.
IT WAS REPORTED THAT WHEN ALL THE MONITORS WERE FLICKERING, THE SURGEON PUNCTURED THE PATIENT'S BOWEL WHILE INSERTING A TROCAR AND HAD TO CONVERT TO OPEN PROCEDURE. AN ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED DUE TO THE PUNCTURED BOWEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1167524 | 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 | Other |