FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT ADDSTAT
MDR report key: 1880127
·
Received October 13, 2010
Report
- Report Number
- 2937094-2010-00723
- Event Type
- Malfunction
- Date Received
- October 13, 2010
- Date of Event
- September 14, 2010
- Report Date
- September 14, 2010
- Manufacturer
- AMS, INNOVATION CENTER - SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER TIP BURNED AT AN UNKNOWN NUMBER OF JOULES. ALSO, IT WAS REPORTED THAT THE PATIENT OUTCOME WAS SUCCESSFUL. THE DEVICE WAS NOT RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT ADDSTAT | SURGICAL FIBER | GEX | AMS, INNOVATION CENTER - SILICON VALLEY | NA | 021H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |