FDA Adverse Event
Malfunction
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2442650
·
Received January 20, 2012
Report
- Report Number
- 3007069406-2012-00004
- Event Type
- Malfunction
- Date Received
- January 20, 2012
- Date of Event
- August 1, 2011
- Report Date
- August 2, 2011
- Manufacturer
- PEAK SURGICAL, INC.
- Product Code
- GEI
- PMA / PMN Number
- K082786
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6) 2012: THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE MARKING ON THE INSULATION PORTION OF THE TIP ASSEMBLY INDICATED THE DEVICE WAS GRIPED AND BENT IN A SEVERE MANNER DURING USE. THE BLADE REMAINED INTACT, THERE WERE NO REPORTS OF PT INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BLADE BROKE DURING A TOTAL KNEE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | PEAK SURGICAL, INC. | PLASMABLADE EXT | 26073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NOT AVAILABLE |