FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
MDR report key: 573401
·
Received February 3, 2005
Report
- Report Number
- 1527736-2005-00453
- Event Type
- Malfunction
- Date Received
- February 3, 2005
- Date of Event
- January 24, 2005
- Report Date
- January 24, 2005
- Manufacturer
- ETHICON ENDO SURGERY, INC.(CINCINNATI)
- Product Code
- LFL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP ASSISTED DISTAL GASTRECTOMY, THE TIP OF THE TISSUE PAD (ABOUT 2MM X 1MM) CAME OFF AFTER CLEANING WITH SALINE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION SURG DEV, CURVED SHEARS, ENDO | ULTRASONIC ACCESSORIES | LFL | ETHICON ENDO SURGERY, INC.(CINCINNATI) | NA | V93529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | GENERATOR, HANDPIECE |