FDA Adverse Event
Summary report: N
SNARE
MDR report key: 1020004
·
Received March 18, 2008
Report
- Report Number
- 1020004
- Date Received
- March 18, 2008
- Date of Event
- January 31, 2008
- Report Date
- March 18, 2008
- Manufacturer
- COOK ENDOSCOPY
- Product Code
- FDI
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
COULD NOT GET ELECTRICAL BURN FROM DEVICE BEING USED FOR SNARE POLYPECTOMY. WENT THROUGH TWO OF THESE (DIFFERENT LOT NUMBERS) BEFORE SWITCHING PRODUCT. COULD NOT GET ELECTRICAL BURN FROM DEVICE. BIOMED DID TROUBLE SHOOTING OF ACTIVE CORD. CONTROL PEDAL AND CORD APPEARED TO BE FUNCTIONING CORRECTLY. SUCCESSFUL BURN WITH THIRD PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SNARE | ELECTRODE, ESU, SNARE | FDI | COOK ENDOSCOPY | NA | W2410168 & W2311847 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |