FDA Adverse Event
Summary report: N
PLASMABLADE 4.0 TISSUE DISSECTION DEVICE
MDR report key: 1873752
·
Received September 28, 2010
Report
- Report Number
- 3007069406-2010-00009
- Date Received
- September 28, 2010
- Report Date
- June 8, 2010
- Manufacturer
- PEAK SURGICAL, INC.
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ON (B)(4) 2010: A RETROSPECTIVE REVIEW OF PAST COMPLAINTS WAS CONDUCTED FOLLOWING A SITE INSPECTION BY FDA. THIS MDR FILLING IS BASED ON THAT REVIEW. THE FACILITY DID NOT RETAIN THE DEVICE. HOWEVER, THE LOT NUMBER WAS PROVIDED. AN INSPECTION OF THE LOT HISTORY RECORD DID NOT NOTE ANY ANOMALIES DURING THE MANUFACTURING OF THIS LOT. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT.
Description of Event or Problem · 1
A PIECE OF THE MATERIAL COATING THE BLADE FLAKED OFF AND HAD TO BE RETRIEVED FROM THE OPERATIVE FIELD DURING A BREAST REDUCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE 4.0 TISSUE DISSECTION DEVICE | GEI | PEAK SURGICAL, INC. | NA | 19802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NOT AVAILABLE |