FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
MDR report key: 620738
·
Received July 11, 2005
Report
- Report Number
- 1527736-2005-03024
- Event Type
- Malfunction
- Date Received
- July 11, 2005
- Date of Event
- April 19, 2005
- Report Date
- June 30, 2005
- Manufacturer
- ETHICON ENDO SURGERY, INC.(CINCINNATI)
- Product Code
- LFL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS R-EN-Y PROCEDURE, INSTRUMENT FAILED FOR NO OBVIOUS REASON IN THE MIDDLE OF THE CASE. ERROR #5 - INSTRUMENT ERROR. NO PT CONSEQUENCE. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION SURG DEV, CURVED SHEARS, ENDO | ULTRACISION ACCESSORY | LFL | ETHICON ENDO SURGERY, INC.(CINCINNATI) | NA | Y4451T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |