FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO 2 EVH SYSTEM
MDR report key: 2192951
·
Received July 21, 2011
Report
- Report Number
- 2242352-2011-00994
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 28, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K101274
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. THE LOT NUMBER COULD NOT BE OBTAINED, SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 METAL PART STARTED TO SEPARATE FROM THE JAWS. THE REPORTED UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS NOT RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO 2 EVH SYSTEM | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR, LLC | VH-4000 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |