FDA Adverse Event
Other
Summary report: N
AEM SUCTION IRRIGATION ELECTRODE - SPATULA
MDR report key: 2253138
·
Received August 31, 2011
Report
- Report Number
- 1722040-2011-00021
- Event Type
- Other
- Date Received
- August 31, 2011
- Date of Event
- August 8, 2011
- Report Date
- August 31, 2011
- Manufacturer
- ENCISION, INC.
- Product Code
- GEI
- PMA / PMN Number
- K100711
- Removal / Correction Number
- Z-3094-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
HOSPITAL HAS BEEN CONTACTED TO GET PATIENT DATA, BUT HAS NOT YET RESPONDED. FOLLOW-UP WILL BE CONTINUED.
Description of Event or Problem · 1
SUCTION IRRIGATION ELECTRODE TIP FELL OFF INSIDE PATIENT DURING A LAP CHOLE PROCEDURE. THE TIP WAS RETRIEVED USING THE MARYLAND GRASPER. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AEM SUCTION IRRIGATION ELECTRODE - SPATULA | ELECTROSURGERY INSTRUMENT | GEI | ENCISION, INC. | ES3882 | RF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |