FDA Adverse Event Injury Summary report: N

VASOVIEW HEMOPRO

MDR report key: 2150754 · Received June 30, 2011

Report

Report Number
MW5021223
Event Type
Injury
Date Received
June 30, 2011
Date of Event
June 23, 2011
Report Date
June 23, 2011
Manufacturer
MAQUET CARDIOVASCULAR
Product Code
GEI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

ENDOSCOPIC VEIN HARVEST-INSULATION TIP TORE FROM TIP OF DEVICE DURING PROCEDURE. (TWO PRODUCTS WITH SAME LOT NUMBER).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-3000 25025389
2 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-3000 25025389

Patients

Seq Age Sex Outcome Treatment
1 71 YR Required Intervention