FDA Adverse Event
Malfunction
Summary report: N
CORE ESSENTIALS PACK
MDR report key: 5013406
·
Received August 19, 2015
Report
- Report Number
- 1932402-2015-00010
- Event Type
- Malfunction
- Date Received
- August 19, 2015
- Date of Event
- July 22, 2015
- Report Date
- August 18, 2015
- Manufacturer
- SYNERGETICS
- Product Code
- HQE
- PMA / PMN Number
- K121675
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE WAS EVALUATED AND DETERMINED THAT THE DEVICE WAS DAMAGED POST RELEASE. IT APPEARS THAT A SUPPY LINE WAS OVER TORQUED ONTO THE CASSETTE.
Description of Event or Problem · 1
VITRECTOMY SYSTEM DISPLAYED AN ERROR WHEN PRIMING. ALL CONNECTIONS WERE CHECKED AND SURGICAL TEAM FOUND AN ABNORMALITY WITH THE DISPOSABLE CASSETTE INTERFACE WITH THE VITRECTOMY SYSTEM. THE ABNORMALITY CAUSED A VACUUM LEAK RESULTING IN AN ERROR MESSAGE. THE SURGERY TEAM SWITCHED TO A DIFFERENT VITRECTOMY SYSTEM CAUSING A 15 MINUTE DELAY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 550034 | CORE ESSENTIALS PACK | VITRECTOMY PROCEDURE PACK | HQE | SYNERGETICS | 70025SP | M503530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |