FDA Adverse Event
Malfunction
Summary report: N
RICHARD-ALLAN
MDR report key: 3573213
·
Received December 20, 2013
Report
- Report Number
- 3573213
- Event Type
- Malfunction
- Date Received
- December 20, 2013
- Date of Event
- December 14, 2013
- Report Date
- December 20, 2013
- Manufacturer
- ASPEN SURGICAL
- Product Code
- KDC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
THE DEVICE, A DISPOSABLE TOOL USED TO RETRACT AND HOLD VESSELS DURING SURGERY, BROKE DURING USE. PER THE DOCTOR'S COMMENT, THIS HAS HAPPENED BEFORE WITH THIS PRODUCT. ALL PARTS OF THE DEVICE WERE RECOVERED FROM THE FIELD, PROCEDURE DELAY WAS ~ 20 MINUTES AND ADDITIONAL BLOOD LOSS WAS ESTIMATED AT 100 ML.======================MANUFACTURER RESPONSE FOR MINI YELLOW VESSEL LOOPS, ASPEN SURGICAL PRODUCTS (PER SITE REPORTER).======================THEY WILL DO AN INVESTIGATION AND EMAIL ME THE RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 669886 | RICHARD-ALLAN | MINI YELLOW VESSEL LOOPS | KDC | ASPEN SURGICAL | 3908 | B35072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | BYPASS.| PATIENT UNDER ANESTHESIA FOR FEMORAL POPLITEAL |