FDA Adverse Event
Malfunction
Summary report: N
SDC3 BASE SYSTEM
MDR report key: 12506444
·
Received September 21, 2021
Report
- Report Number
- 0002936485-2021-00510
- Event Type
- Malfunction
- Date Received
- September 21, 2021
- Date of Event
- August 25, 2021
- Report Date
- November 30, 2021
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GCJ
- UDI-DI
- 07613327056150
- PMA / PMN Number
- K160332
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. ALLEGED FAILURE: EIB MARDELLE, POWERING DOWN AT RANDOM TIMES DURING PROCEDURE. PER ADDITIONAL INFORMATION, THERE WAS LOSS OF IMAGE FOR 2 MINUTES. THE PROBABLE ROOT CAUSE/S COULD BE CAPTURE CARD FAILURE OR SOFTWARE FAILURE. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE DURING PROCEDURE.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1408110 | SDC3 BASE SYSTEM | LAPARASCOPE, GENERAL & PLASTIC SURGERY | GCJ | STRYKER ENDOSCOPY-SAN JOSE | 0240060100 | 07613327056150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |