FDA Adverse Event
Other
Summary report: N
MANUAL DETACHABLE SURGICAL INSTRUMENT
MDR report key: 3592645
·
Received January 7, 2014
Report
- Report Number
- 1223422-2014-00001
- Event Type
- Other
- Date Received
- January 7, 2014
- Date of Event
- December 10, 2013
- Report Date
- January 6, 2013
- Manufacturer
- MICROLINE SURGICAL INC
- Product Code
- GEI
- PMA / PMN Number
- K981389
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING A PROCEDURE, FENESTRATED GRASPER TIP BROKE AND FELL INTO THE PT. THE TIP WAS RETRIEVED. NO ONE WAS HARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11604 | MANUAL DETACHABLE SURGICAL INSTRUMENT | RE-NEW FORCEPS LAPAROSCOPIC | GEI | MICROLINE SURGICAL INC | 3222 | 00114438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |