FDA Adverse Event
Other
Summary report: N
FLASMABLADE TNA TISSUE DISSECTION DEVICE
MDR report key: 1912807
·
Received November 5, 2010
Report
- Report Number
- 3007069406-2010-00012
- Event Type
- Other
- Date Received
- November 5, 2010
- Date of Event
- October 4, 2010
- Report Date
- October 8, 2010
- Manufacturer
- PEAK SURGICAL INC.
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY DID NOT RETAIN THE DEVICE AND DID NOT PROVIDE A LOT NUMBER FOR THE TNA DEVICE. THEREFORE, THE MANUFACTURER COULD NOT CONDUCT AN INVESTIGATION OF THE DEVICE OR THE LOT HISTORY RECORD. MANUFACTURER HAS NO ADDITIONAL INFORMATION. ATTEMPTED TO CONTACT PHYSICIAN THREE TIMES OVER THE PAST MONTH FOR ADDITIONAL DETAILS REGARDING THE PROCEDURE AND PATIENT STATUS BUT THE PHYSICIAN DID NOT RETURN THE CALLS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT.
Description of Event or Problem · 1
ONE OF THE TIPS DISCONNECTED FROM HANDPIECE DURING A PROCEDURE. PATIENT HAD A SMALL INSIGNIFICANT BURN ON INSIDE OF MOUTH. SURGEON DID NOT SEEM OVERLY CONCERNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLASMABLADE TNA TISSUE DISSECTION DEVICE | GEI | PEAK SURGICAL INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | NOT AVAILABLE |