FDA Adverse Event
Injury
Summary report: N
ULTRACISION SURGICAL DEVICE, CURVED SHEARS, ENDO
MDR report key: 5130043
·
Received November 1, 2004
Report
- Report Number
- 1527736-2004-03902
- Event Type
- Injury
- Date Received
- November 1, 2004
- Date of Event
- August 26, 2004
- Report Date
- October 11, 2004
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GEI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE SENT: 11/02/2004. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE BLADE OF SCISSORS FELL OFF RESULTING IN THE CONVERSION FROM LAPAROSCOPIC TO AN OPEN PROCEDURE WITH A SIGMOIDOSCOPY. NO OTHER CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION SURGICAL DEVICE, CURVED SHEARS, ENDO | ULTRASONIC ACCESSORY | GEI | ETHICON ENDO-SURGERY, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |