FDA Adverse Event
Injury
Summary report: N
VASOVIEW 7 XB
MDR report key: 3763532
·
Received April 8, 2014
Report
- Report Number
- 2242352-2014-00401
- Event Type
- Injury
- Date Received
- April 8, 2014
- Date of Event
- February 5, 2014
- Report Date
- March 13, 2014
- Manufacturer
- MAQUET CARDIOIVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K041981
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE PETAL WAS ACCIDENTALLY STEPPED ON WHILE THE VASOVIEW 7 XB TOOL LAID ON THE PATIENT SIDE AND BURNED THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211446 | VASOVIEW 7 XB | ENDOSCOPIC VESSEL HARVESTING | GEI | MAQUET CARDIOIVASCULAR, LLC | VH-3200 | 25088955 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |