FDA Adverse Event
Malfunction
Summary report: N
7 MM EXTENDED LENGTH ENDOSCOPE
MDR report key: 3020987
·
Received March 20, 2013
Report
- Report Number
- 2242352-2013-00271
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 27, 2013
- Report Date
- March 4, 2013
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GCJ
- PMA / PMN Number
- K014250
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. 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 HOSP REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE IMAGE WAS DARK WHILE USING THE ENDOSCOPE. THE HOSP DID NOT REPORT ANY PT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115267 | 7 MM EXTENDED LENGTH ENDOSCOPE | ENDOSCOPIC VESSEL HARVESTING | GCJ | MAQUET CARDIOVASCULAR, LLC | VH-1111 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |