FDA Adverse Event
Malfunction
Summary report: N
PROCISE MINI LARYNGEAL WAND (MLW), CII
MDR report key: 2467663
·
Received February 3, 2012
Report
- Report Number
- 3006524618-2012-00280
- Event Type
- Malfunction
- Date Received
- February 3, 2012
- Date of Event
- January 5, 2012
- Report Date
- January 6, 2012
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K070374
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING A LARYNGEAL PAPILLOMA PROCEDURE THE PHYSICIAN WAS UTILIZING A PROCISE MINI LARYNGEAL WAND (MLW). WHILE THE PHYSICIAN WAS ABLATING TISSUE THE WAND CLOGGED AND THE PHYSICIAN WAS UNABLE TO ACHIEVE SALINE DELIVERY OR ASPIRATION. A SECOND WAND WAS OPENED AND THE PROCEDURE WAS COMPLETED. NO PT INJURIES WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROCISE MINI LARYNGEAL WAND (MLW), CII | ELECTROSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORP. | 5923510-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Required Intervention |