FDA Adverse Event
Other
Summary report: N
THERMAL LIGATING SHEARS
MDR report key: 3020624
·
Received March 20, 2013
Report
- Report Number
- 1223422-2013-00009
- Event Type
- Other
- Date Received
- March 20, 2013
- Report Date
- March 18, 2013
- Manufacturer
- MICROLINE SURGICAL INC.
- Product Code
- GEI
- PMA / PMN Number
- K062257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE DEVICE WAS TAKEN OUT DURING THE OPERATION TO BE CLEANED. WHEN THE OPERATING ROOM NURSE ATTEMPTED TO GENTLY CLEAN THE TIP, THE SILICONE PEELED OFF FROM ONE SIDE OF THE JAW. THE DEVICE WAS EXCHANGED FOR A NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116846 | THERMAL LIGATING SHEARS | TLS3 14C | GEI | MICROLINE SURGICAL INC. | 131-136D | 201071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |