FDA Adverse Event
Injury
Summary report: N
ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT
MDR report key: 1053129
·
Received May 8, 2008
Report
- Report Number
- 1527736-2008-02836
- Event Type
- Injury
- Date Received
- May 8, 2008
- Report Date
- April 14, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GEI
- PMA / PMN Number
- K002981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A VIDEO SPLENECTOMY PROCEDURE, THE DEVICE DID NOT WORK WHEN CONNECTED TO THE GENERATOR. MANY ATTEMPTS WERE TRIED, BUT IT DID NOT WORK. THE SURGERY HAD TO BE CONVERTED TO AN OPEN PROCEDURE. THE PT IS IN GOOD CONDITION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT | GEI | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | D4HZ8T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |