FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM
MDR report key: 1182659
·
Received September 25, 2008
Report
- Report Number
- 2953148-2008-00814
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 18, 2008
- Report Date
- September 5, 2008
- Manufacturer
- GUIDANT CARDIAC SURGERY
- Product Code
- GEI
- PMA / PMN Number
- K052274
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO DEVICE WOULD NOT TURN OFF WHEN THE ACTIVATION TOGGLE WAS ACTIVATED. THE JAWS WERE RED HOT AND STARTED OVERHEATING. THE DEVICE'S CORD WAS IMMEDIATELY UNPLUGGED. THE HOSPITAL USED A SECOND HEMOPRO DEVICE, SUCCESSFULLY COMPLETED THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | GUIDANT CARDIAC SURGERY | VH-3000 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |