FDA Adverse Event
Malfunction
Summary report: N
VASO VIEW HEMOPRO
MDR report key: 2201487
·
Received August 4, 2011
Report
- Report Number
- 2242352-2011-01039
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 12, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K052274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY BEING INVESTIGATED AND THE RESULTS ARE BEING EVALUATED AND ANALYZED WITH SIMILAR EVENTS. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETE. ITEMS MARKED "NI" ARE UNKNOWN TO US AT THIS TIME. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO WAS 'BADLY DEFECTIVE'. THE JAWS MELTED AND THERE WAS SMOKE. NO ELECTRICAL ISSUES WERE OBSERVED. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASO VIEW HEMOPRO | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR, LLC | VH-3000 | 25035533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |