FDA Adverse Event
Malfunction
Summary report: N
ROTICULATOR ENDO DISSECT 5MM INSTRUMENT
MDR report key: 3172856
·
Received May 30, 2013
Report
- Report Number
- 2647580-2013-00301
- Event Type
- Malfunction
- Date Received
- May 30, 2013
- Date of Event
- May 2, 2013
- Report Date
- May 7, 2013
- Manufacturer
- COVIDIEN, FORMERLY USSC P
- Product Code
- GCJ
- PMA / PMN Number
- K914753
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: BEFORE USE ON PT, THE ARTICULATING TRANSPARENT PART WAS FOUND FRAYED. A NEW DEVICE WAS OPENED TO COMPLETE PROCEDURE. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 239164 | ROTICULATOR ENDO DISSECT 5MM INSTRUMENT | DISPOSABLE SURGICAL ACCESSORY | GCJ | COVIDIEN, FORMERLY USSC P | P2H0766X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |