FDA Adverse Event
Other
Summary report: N
ETHICON
MDR report key: 501357
·
Received October 27, 2003
Report
- Report Number
- 501357
- Event Type
- Other
- Date Received
- October 27, 2003
- Date of Event
- December 1, 2002
- Report Date
- May 1, 2003
- Manufacturer
- ETHICON ENDO SURGERY, INC.
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A SMALL PIECE OF TITANIUM BROKE OFF OF INSTRUMENT. SURGEON SEARCHED SITE BUT PIECE WAS NOT FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON | HARMONIC SCALPEL CURVED SHEERS | LFL | ETHICON ENDO SURGERY, INC. | * | R4UR6P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |