FDA Adverse Event
Malfunction
Summary report: N
ENDO PADDLE RETRACT 12MM INSTRUMENT
MDR report key: 2933393
·
Received December 21, 2012
Report
- Report Number
- 2647580-2012-00790
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 26, 2012
- Report Date
- November 26, 2012
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- GAD
- PMA / PMN Number
- K914190
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: GYNECOLOGY. ACCORDING TO THE REPORTER: THE DEVICE IN QUESTION WAS DEPLOYED INTO THE PATIENT VIA A 12MM VERSASTEP TROCAR. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL TIP OF THE INSERTION SHEATH HAD "BURST". SURGEON WAS CONCERNED ABOUT ANY REMAINING PARTICLES FROM DEVICE, BUT UPON INSPECTION COULD NOT FIND ANY REMAINING IN THE PATIENT. OTHER PRODUCTS USED WITH DEVICE: 12MM VERSASTEP TROCAR. 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 PADDLE RETRACT 12MM INSTRUMENT | SINGLE USE LAPAROSCOPIC HAND INSTRUMENT | GAD | COVIDIEN, FORMERLY USSC | P2E0321X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |