FDA Adverse Event
Malfunction
Summary report: N
7 MM EXTENDED LENGTH ENDOSCOPE
MDR report key: 1760941
·
Received July 14, 2010
Report
- Report Number
- 2242352-2010-01872
- Event Type
- Malfunction
- Date Received
- July 14, 2010
- Date of Event
- June 15, 2010
- Report Date
- June 15, 2010
- Manufacturer
- MAQUET CARDIOSVASCULAR, LLC
- Product Code
- GCJ
- PMA / PMN Number
- K014250
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(4), 2010, FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE 7 MM EXTENDED LENGTH ENDOSCOPE WAS GENERATING A CLOUDY IMAGE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7 MM EXTENDED LENGTH ENDOSCOPE | SCOPE | GCJ | MAQUET CARDIOSVASCULAR, LLC | VH-1111 | 326686 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |