FDA Adverse Event
Malfunction
Summary report: N
NEUROBLATE
MDR report key: 3624950
·
Received December 12, 2013
Report
- Report Number
- 3009970070-2013-00009
- Event Type
- Malfunction
- Date Received
- December 12, 2013
- Date of Event
- November 15, 2013
- Report Date
- December 12, 2013
- Manufacturer
- MONTERIS MEDICAL CORP
- Product Code
- GEX
- PMA / PMN Number
- K120561
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DIFFUSE-TIP PROBE (S/N: (B)(4)) WAS DAMAGED UPON OPENING. WHEN INSPECTING THE PILOT LIGHT EMITTED FROM THE PROBE PRIOR TO INSERTION, IT LOOKED EXTREMELY WEAK, AND THE USER WAS UNABLE TO SEE THE BEAM WHEN SHOWN AGAINST HIS GLOVE. THE FIBER CONNECTION WAS REMOVED FROM CONNECTOR BOX ON THE IP AND THE INTENSITY OF LIGHT AT THE IP CONNECTOR BOX SEEMED AS IT NORMALLY WOULD. THE FIBER WAS RECONNECTED TO THE IP AND THE SIGNAL WAS NO STRONGER. THERE WAS A STRONG LIGHT AT THE CONNECTION POINT BETWEEN THE FIBER AND IP WHICH SEEMED TO BE WHERE THE PROBE WAS DAMAGED. THE PROBE HAS BEEN WAS SCRAPPED AT THIS POINT AND KEPT BY RISK MANAGEMENT AT HOSPITAL AND WILL BE RETURNED TO MONTERIS MEDICAL AFTER INVESTIGATION. PRODUCT WAS NOT INTRODUCED TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651327 | NEUROBLATE | GEX - POWERED LASER SURGICAL INSTRUMENT | GEX | MONTERIS MEDICAL CORP | 20414-1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |