FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM
MDR report key: 1150983
·
Received August 28, 2008
Report
- Report Number
- 3005075853-2008-01405
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 11, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- 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
DATE SENT: 08/28/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED BY THE AFFILIATE THAT DURING A CABG PROCEDURE, THREE BLADES WERE BROKEN IN A ROW. THE SECOND AND THIRD DEVICES HAD A BURN MARK ON THE BLADE AND ALSO AN ERROR WAS DISPLAYED ON THE MAIN BODY. THE HAND PIECE WAS USED WITHOUT ANY PROBLEMS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. PLEASE TAKE PHOTOS FOR CUSTOMER. THREE DEVICES WILL BE RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM | GEI | ETHICON ENDO-SURGERY, LLC | NA | C4G036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |