FDA Adverse Event
Malfunction
Summary report: N
GUIDANT VASOVIEW 7 ENDOSCOPIC VESSEL HARVESTING SYSTEM
MDR report key: 1023531
·
Received April 2, 2008
Report
- Report Number
- 2953148-2008-00316
- Event Type
- Malfunction
- Date Received
- April 2, 2008
- Date of Event
- March 14, 2008
- Report Date
- March 17, 2008
- Manufacturer
- GUIDANT CARDIAC SURGERY
- Product Code
- GCJ
- PMA / PMN Number
- K030512
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AFTER THE PROCEDURE, THE HOSP DISCARDED THE PRODUCT. SINCE THE PRODUCT WAS NOT RETURNED TO CARDIAC SURGERY FOR EVAL, IT WILL BE DIFFICULT TO CONFIRM THE REPORTED PROBLEM. A LHR REVIEW CANNOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE HOSP.
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING PRE-TEST PREPARATION OF AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DEVICE WOULD NOT CAUTERIZE AND WAS GETTING ANY ENERGY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDANT VASOVIEW 7 ENDOSCOPIC VESSEL HARVESTING SYSTEM | GCJ | GUIDANT CARDIAC SURGERY | VH-3200 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |