FDA Adverse Event
Malfunction
Summary report: N
200 MICRON TFL SINGLE USE FIBER
MDR report key: 19370530
·
Received May 22, 2024
Report
- Report Number
- 3011050570-2024-00201
- Event Type
- Malfunction
- Date Received
- May 22, 2024
- Date of Event
- March 23, 2024
- Report Date
- May 22, 2024
- Manufacturer
- GYRUS ACMI, INC.
- Product Code
- GEX
- PMA / PMN Number
- K183647
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS RELATED TO MFR REPORT # 3011050570 - 2024 - 00199 (1/2).
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING PREPARATION FOR USE OF THE SINGLE USE FIBER FOUND SPARKING AND FLAMES. THERE WERE NO REPORTS OF PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1596452 | 200 MICRON TFL SINGLE USE FIBER | POWERED LASER SURGICAL INSTRUMENT | GEX | GYRUS ACMI, INC. | TFL-FBX200S | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | TFL-PLS: SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM |