FDA Adverse Event
Other
Summary report: N
AEM FIXED TIP ELECTRODE, REUSABLE, L-WEDGE
MDR report key: 1562858
·
Received December 18, 2009
Report
- Report Number
- 1722040-2009-00004
- Event Type
- Other
- Date Received
- December 18, 2009
- Date of Event
- November 14, 2007
- Report Date
- December 11, 2009
- Manufacturer
- ENCISION, INC.
- Product Code
- GEI
- PMA / PMN Number
- K912780
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DAMAGED TIP INSULATION IS NOTED ON THE INSTRUCTIONS FOR USE FOR THIS DEVICE TO BE AN END OF LIFE INDICATOR, AND IT IS RECOMMEND TO DISCONTINUE USE.
Description of Event or Problem · 1
REPORTED BURN TO LIVER DURING UNKNOWN PROCEDURE USING FIXED TIP ELECTRODE. SALES REPRESENTATIVE SPOKE WITH THE SURGEON, WHO STATED DAMAGED TIP INSULATION WAS NOTED BEFORE THE PROCEDURE, BUT THE INSTRUMENT WAS USED. THE ALLEGED BURN WAS IN THE AREA OF THE SURGEON'S VIEW DURING THE PROCEDURE. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AEM FIXED TIP ELECTRODE, REUSABLE, L-WEDGE | LAPAROSCOPIC SURGICAL DEVICE | GEI | ENCISION, INC. | ES3512B | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |