FDA Adverse Event
Malfunction
Summary report: N
VALLEY LAB
MDR report key: 168384
·
Received May 19, 1998
Report
- Report Number
- MW1013842
- Event Type
- Malfunction
- Date Received
- May 19, 1998
- Date of Event
- February 5, 1998
- Report Date
- April 29, 1998
- Manufacturer
- VALLEY LAB INC.
- Product Code
- KNS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT JERKED DURING COLONOSCOPY WHEN HOT BIOPSY FORCEP DELIVERED CAUTERY TO POLYP VIA VALLEY LAB FORCE 18 GENERATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VALLEY LAB | BOVIE | KNS | VALLEY LAB INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other |