FDA Adverse Event
Other
Summary report: N
TLS2 35C
MDR report key: 2925242
·
Received January 17, 2013
Report
- Report Number
- 1223422-2012-00006
- Event Type
- Other
- Date Received
- January 17, 2013
- Report Date
- January 14, 2013
- Manufacturer
- MICROLINE SURGICAL, INC
- Product Code
- GEI
- PMA / PMN Number
- K062257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TLS2 35C WAS NOT RETURNED IN A TIMELY MANNER, THEREFORE, NO INVESTIGATION COULD BE CONDUCTED.
Description of Event or Problem · 1
THE INSULATION TORE AFTER 10 MINUTES OF USE DURING ERAH SURGERY. NO TROCAR WAS USED, NO MECHANICAL STRESS ON THE RETRACTOR AND THE INSTRUMENT WAS USED IN A NORMAL MANNER. NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26779 | TLS2 35C | THERMAL LIGATING SHEARS | GEI | MICROLINE SURGICAL, INC | 132-121D | 206008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |