FDA Adverse Event
Malfunction
Summary report: N
VERSAPULSE POWERSUITE
MDR report key: 15382904
·
Received September 8, 2022
Report
- Report Number
- 2124215-2022-34793
- Event Type
- Malfunction
- Date Received
- September 8, 2022
- Date of Event
- August 23, 2022
- Report Date
- September 8, 2022
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- UDI-DI
- 07290109146195
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SYSTEM WAS STILL PRODUCING A BURNING SMELL AT A SECOND CASE. THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2123259 | VERSAPULSE POWERSUITE | POWERED LASER SURGICAL INSTRUMENT | GEX | LUMENIS LTD | 0638-803-01 | 0000000248 | 07290109146195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |