FDA Adverse Event
Malfunction
Summary report: N
ENDO RETRACT II 10MM INSTRUMENT
MDR report key: 2820563
·
Received October 4, 2012
Report
- Report Number
- 2647580-2012-00630
- Event Type
- Malfunction
- Date Received
- October 4, 2012
- Date of Event
- September 13, 2012
- Report Date
- September 13, 2012
- Manufacturer
- COVIDIEN, FORMERLY USSC
- 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
ACCORDING TO THE REPORTER: WHILE USING THE ENDO RETRACT, A PIECE OF BLACK PLASTIC BROKE AWAY FROM THE INSTRUMENT WHERE THE FAN ARTICULATES. A PIECE FELL INTO THE PATIENT AND WAS RETRIEVED USING A GRASPER. THEY THEN USED A SECOND DEVICE AND THE SAME THING HAPPENED. TWO INSTRUMENTS ARE BEING RETURNED WITH THE SAME LOT NUMBER. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO RETRACT II 10MM INSTRUMENT | SINGLE USE LAPAROSCOPIC HAND INSTR | GCJ | COVIDIEN, FORMERLY USSC | P2G0196X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |