FDA Adverse Event
Malfunction
Summary report: N
DC EXTENSION CABLE
MDR report key: 2844250
·
Received November 8, 2012
Report
- Report Number
- 2242352-2012-01202
- Event Type
- Malfunction
- Date Received
- November 8, 2012
- Date of Event
- October 24, 2012
- Report Date
- October 25, 2012
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K052274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT AFTER AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHILE CLEANING THE DC EXTENSION CABLE, THE INSULATION WAS OBSERVED TO BE STRIPPED AT THE END OF THE CORD. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DC EXTENSION CABLE | ENDOSCOPIC VESSEL HARVESTING | GEI | MAQUET CARDIOVASCULAR, LLC | VH-3030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |