FDA Adverse Event
Malfunction
Summary report: N
ETHICON ENDO-SURGERY INC.
MDR report key: 272825
·
Received April 5, 2000
Report
- Report Number
- MW1018600
- Event Type
- Malfunction
- Date Received
- April 5, 2000
- Date of Event
- March 23, 2000
- Report Date
- April 5, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- KNS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WHEN ATTEMPTED TO USE HARMONIC SCALPEL THE HANDPIECE DID NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY INC. | 1 ULTRACISION HARMONIC SCALPEL LCS-5 KNIFE DOWN 15 MM ACTIVE | KNS | ETHICON ENDO-SURGERY, INC. | LCSK5 5MM LCS | N4GP9W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |