FDA Adverse Event
Malfunction
Summary report: N
ACTIVE RETURN CORD, NON-STERILE, FORCEPS
MDR report key: 2153492
·
Received June 21, 2011
Report
- Report Number
- 2242352-2011-00660
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 23, 2011
- Report Date
- May 27, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K870981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE BIPOLAR CORD WAS NOT WORKING. THE CORD WOULD NOT WORK AT ALL. ANOTHER CORD WAS USED TO COMPLETE THE PROCEDURE. THERE WERE PATIENT EFFECTS. THE PRODUCT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVE RETURN CORD, NON-STERILE, FORCEPS | BIPOLAR CORD | GEI | MAQUET CARDIOVASCULAR, LLC | 1838 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |