FDA Adverse Event
Malfunction
Summary report: N
ENDO RETRACT II 10MM INSTRUMENT
MDR report key: 2112223
·
Received April 29, 2011
Report
- Report Number
- 2647580-2011-00290
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Report Date
- April 14, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K920068
- 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
PROCEDURE TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: THE SURGEON WAS USING THE ENDO RETRACT DEVICE TO RETRACT A KIDNEY. (B)(6) THEN REALIZED THAT SOME FRAGMENTS OF PLASTIC HAD DISLODGED FROM THE INSTRUMENT. THESE WERE CIRCLE SHAPED AREAS OF BLACK PLASTIC WHICH ARE BESIDE THE POINT OF ARTICULATION IN THE INSTRUMENT. (B)(6) RETRIEVED THE FRAGMENTS OF PLASTIC FROM THE PATIENT. THESE ARE INCLUDED IN THE RETURNED SAMPLE. A NEW INSTRUMENT WITH A DIFFERENT LOT NUMBER WAS USED AND THE PROCEDURE CONTINUED WITHOUT FURTHER EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO RETRACT II 10MM INSTRUMENT | SINGLE USE LAPAROSCOPIC HAND INSTRUMENT | GCJ | USSC PUERTO RICO | POM0992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |