FDA Adverse Event
Malfunction
Summary report: N
GUIDANT 7 MM DISSECTION ENDOSCOPE
MDR report key: 1051605
·
Received May 19, 2008
Report
- Report Number
- 2953148-2008-00532
- Event Type
- Malfunction
- Date Received
- May 19, 2008
- Date of Event
- April 28, 2008
- Report Date
- April 28, 2008
- Manufacturer
- GUIDANT CARDIAC SURGERY
- Product Code
- GCJ
- PMA / PMN Number
- K014250
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
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 AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, IT WAS IDENTIFIED WHEN LOOKING THROUGH THE EYE PIECE THAT THE IMAGE WAS CLOUDY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDANT 7 MM DISSECTION ENDOSCOPE | GCJ | GUIDANT CARDIAC SURGERY | VH-1111 | 235861 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |