FDA Adverse Event
Malfunction
Summary report: N
365 MICRON FIBER WITH FLAT TIP
MDR report key: 1953287
·
Received January 7, 2011
Report
- Report Number
- 1419951-2011-00001
- Event Type
- Malfunction
- Date Received
- January 7, 2011
- Date of Event
- May 12, 2010
- Report Date
- March 9, 2011
- Manufacturer
- TRIMEDYNE, INC.
- Product Code
- GEX
- PMA / PMN Number
- K973172
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): DEVICE NOT RETURNED--EVALUATION BASED ON REPORTER'S NARRATIVE. (B)(4): DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
"THEY ATTEMPTED TO DEMO ONE OF OUR FIBERS (365 MICRON) AS A SINGLE-USE AND IT BROKE TOWARD THE MIDDLE OF THE FIBER AND THEY INFORMED ME THAT IT STARTED SPARKING AS WELL."THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 365 MICRON FIBER WITH FLAT TIP | LASER FIBER | GEX | TRIMEDYNE, INC. | B365SMA | 710019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |