FDA Adverse Event
Malfunction
Summary report: N
PKG CONNECTED OR HUB BASE SYSTEM
MDR report key: 19472419
·
Received June 5, 2024
Report
- Report Number
- 0002936485-2024-00440
- Event Type
- Malfunction
- Date Received
- June 5, 2024
- Date of Event
- May 7, 2024
- Report Date
- November 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
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 0
THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: IMAGE WAS LOST. CONFIRMED FAILURE: UPDATE SOFTWARE. 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 AND ¿ CYBERSECURITY.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1078178 | 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 |