FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL
MDR report key: 2143673
·
Received June 23, 2011
Report
- Report Number
- 2143673
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 14, 2011
- Report Date
- June 23, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OR, US
Narratives
Description of Event or Problem · 1
DEVICE FAILED TO CUT AND MADE CONSTANT "SQUEAKING" NOISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALPEL | HARMONIC SCALPEL | LFL | ETHICON ENDO-SURGERY, INC. | LCSC5 | G4UA4P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NONE KNOWN. |