FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO EVH SYSTEM
MDR report key: 1900029
·
Received October 22, 2010
Report
- Report Number
- 2242352-2010-03152
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 21, 2010
- Report Date
- September 23, 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
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND 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, THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM "SHORTED OUT." NO INFO IS AVAILABLE REGARDING HOW THE PROCEDURE WAS COMPLETED, THE SURGEON'S NAME AND WHETHER THERE WERE ANY PT EFFECTS. THE REPORTER ATTEMPTED TO RETRIEVE THAT INFO FROM THE HOSPITAL STAFF BUT WAS TOLD THERE IS NO ADDITIONAL INFO. THE PRODUCT IS RETURNING.
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 | 25017307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |