FDA Adverse Event
Malfunction
Summary report: N
MISEAL DISPOSABLE KIT
MDR report key: 2243912
·
Received August 24, 2011
Report
- Report Number
- 2954339-2011-00020
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- July 28, 2011
- Report Date
- August 23, 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 TIP KIT USED IN SURGERY WAS NOT RETURNED IN A TIMELY MANNER, THEREFORE NO INVESTIGATION COULD BE CONDUCTED.
Description of Event or Problem · 1
AFTER APPROX 3 HOURS INTO A LAP NISSEN FUNDOPLICATION THE SILICONE BOOT STARTED TO PEEL. WHEN THE SURGEON PULLED THE INSTRUMENT THROUGH THE TROCAR, THE PIECE CAME OFF INSIDE THE PT. THE SURGEON BELIEVES IT WAS RETRIEVED. OPENED A NEW TIP TO COMPLETE THE CASE. NO PT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MISEAL DISPOSABLE KIT | MISEAL DISPOSABLE TIP AND CABLE | GEI | STARION INSTRUMENTS | 452-131D | 103011A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |