FDA Adverse Event
Malfunction
Summary report: N
TLS3 104C, THERMAL LIGATING SHEARS
MDR report key: 2052007
·
Received March 2, 2011
Report
- Report Number
- 2954339-2011-00003
- Event Type
- Malfunction
- Date Received
- March 2, 2011
- Report Date
- March 1, 2011
- Manufacturer
- STARION INSTRUMENTS
- Product Code
- GEI
- PMA / PMN Number
- K062257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE TLS3 14C WAS NOT RETURNED, THEREFORE NO INVESTIGATION COULD BE CONDUCTED.
Description of Event or Problem · 1
DURING A GYN OPEN HYSTERECTOMY, THE TIP STARTED TO MELT OFF. THIS WAS NOTICED AND THE INSTRUMENT WAS NOT USED AFTER THE TIP STARTED TO BEND AWAY. THE TIP DID NOT COME OFF THE JAWS, IT HAD ONLY PEELED BACK. THE INSTRUMENT WAS DISCARDED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TLS3 104C, THERMAL LIGATING SHEARS | TLS3 14C | GEI | STARION INSTRUMENTS | 132-134D | 907016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |