FDA Adverse Event
Malfunction
Summary report: N
POWERED LASER SURGICAL INSTRUMENT
MDR report key: 15302196
·
Received August 26, 2022
Report
- Report Number
- 15302196
- Event Type
- Malfunction
- Date Received
- August 26, 2022
- Date of Event
- April 29, 2022
- Report Date
- June 22, 2022
- Manufacturer
- NEW STAR LASERS, INC.
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
ALL LASERS FAILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2325643 | POWERED LASER SURGICAL INSTRUMENT | GEX | NEW STAR LASERS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26645 DA | Unknown |