FDA Adverse Event
Malfunction
Summary report: N
POLYPECTOMY SNARE
MDR report key: 29490
·
Received January 25, 1996
Report
- Report Number
- MW1008182
- Event Type
- Malfunction
- Date Received
- January 25, 1996
- Date of Event
- January 17, 1996
- Report Date
- January 25, 1996
- Manufacturer
- U.S. ENDOSCOPY GROUP, INC.
- Product Code
- FDI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THREE SNARES BUCKLED AT THE HANDLE WIRE WHEN OPENED DURING PROCEDURE. SNARE FROM A DIFFERENT LOT NUMBER USED WITHOUT PROBLEM. NO INJURY TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYPECTOMY SNARE | POLYPECTOMY SNARE | FDI | U.S. ENDOSCOPY GROUP, INC. | 174307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |