FDA Adverse Event
Malfunction
Summary report: N
ENDO CLINCH II 5MM INSTRUMENT
MDR report key: 3850747
·
Received March 20, 2014
Report
- Report Number
- 2647580-2014-00194
- Event Type
- Malfunction
- Date Received
- March 20, 2014
- Date of Event
- February 14, 2014
- Report Date
- February 25, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- HDA
- PMA / PMN Number
- K903205
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: TESTED THE GRASPER ON OPENING AND IT APPEARED TO BE IN WORKING ORDER. HOWEVER, UPON THE INITIAL USE THE JAWS FAILED TO OPERATE AND APPEARED TO BE DETACHED FROM THE INTERNAL MECHANISM. NO INJURY TO PATIENT. THE DEVICE WAS TAKEN OUT OF USE. DETAILS PASSED TO THE LOCAL REP TO FOLLOW UP AND SAMPLE REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166756 | ENDO CLINCH II 5MM INSTRUMENT | ENDO CLINCH | HDA | COVIDIEN, FORMERLY USSC | P3J0143X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |