FDA Adverse Event
Malfunction
Summary report: N
ENDO DISSECT 5MM INSTRUMENT
MDR report key: 1991227
·
Received January 28, 2011
Report
- Report Number
- 2647580-2011-00071
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Report Date
- December 22, 2010
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GET
- PMA / PMN Number
- K904578
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE JAWS WERE BROKEN. NO ADDITIONAL INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO DISSECT 5MM INSTRUMENT | DISPOSABLE SURGICAL DEVICE | GET | USSC PUERTO RICO | P9L0078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |