FDA Adverse Event
Malfunction
Summary report: N
DORNIER MEDTECH AMERICA, INC.
MDR report key: 19982730
·
Received August 14, 2024
Report
- Report Number
- 1037955-2024-00032
- Event Type
- Malfunction
- Date Received
- August 14, 2024
- Report Date
- August 12, 2024
- Manufacturer
- DORNIER MEDTECH AMERICA, INC.
- Product Code
- GEX
- UDI-DI
- 00810116020492
- PMA / PMN Number
- K121938
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO DEVICE WAS RETURNED TO DORNIER WITHIN THE TIMEFRAME OF THIS INVESTIGATION. IT IS RECOGNIZED THAT ALL LASER FIBERS MANUFACTURED BY DORNIER MEDTECH AMERICA ARE SUBJECT TO 100% INSPECTION FOR VISUAL DEFECTS AS WELL AS POWER PERFORMANCE TESTING WHICH CONFIRMS THE DEVICE IS OPERATING WITHIN SPECIFICATION. IT IS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE BURN DAMAGE REPORTED WITHOUT ACCESS TO EVALUATE THE SUSPECT DEVICE.
Description of Event or Problem · 0
DORNIER RECEIVED COMPLAINT INFORMATION REGARDING A LASER FIBER WHICH HAD REPORTEDLY BURNED "AT THE END OF THE SURGERY".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 546565 | DORNIER MEDTECH AMERICA, INC. | HOLMIUM LASER FIBER | GEX | DORNIER MEDTECH AMERICA, INC. | K2013324 | F3523S | 00810116020492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |