FDA Adverse Event
Malfunction
Summary report: N
ENDO RETRACT II 10MM INSTRUMENT
MDR report key: 2191819
·
Received July 29, 2011
Report
- Report Number
- 2647580-2011-00510
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- July 13, 2011
- Report Date
- July 19, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K920068
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: NEPHRECTOMY. ACCORDING TO THE RPTR: IN USE, IT WAS NOTICED THAT A METAL PIECE, WHICH LOOKED LIKE A WIRE WAS FOUND IN CAVITY. THE PIECE WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO BLEEDING OCCURRED. NO TISSUE WAS DAMAGED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO RETRACT II 10MM INSTRUMENT | SINGLE USE LAPAROSCOPIC HAND INSTR | GCJ | USSC PUERTO RICO | P1B0013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |