FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO EVH SYSTEM
MDR report key: 1840651
·
Received September 17, 2010
Report
- Report Number
- 2242352-2010-02841
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- August 18, 2010
- Report Date
- August 19, 2010
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K052274
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(6), 2010, FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING DEVICE STOPPED PRODUCING DISTAL INSUFFLATION. THE DEVICE WAS UNPLUGGED, REMOVED AND ANOTHER VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PT EFFECTS. THE PRODUCT IS RETURNING. THE PRODUCT WAS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO EVH SYSTEM | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR, LLC | VH-3000 | 25016422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |