FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, SCISSORGRIP HANDLE, 15MM ACTIVE
MDR report key: 1190552
·
Received October 9, 2008
Report
- Report Number
- 1527736-2008-03461
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- May 12, 2008
- Report Date
- May 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
- JA
- 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 AN UNK PROCEDURE, THE TISSUE PAD FELL OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, SCISSORGRIP HANDLE, 15MM ACTIVE | NONE | GEI | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | D4GH3R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |