FDA Adverse Event
Injury
Summary report: N
PREMIUM SURGICLIP II M-11.5 TITANIUM
MDR report key: 3042015
·
Received April 2, 2013
Report
- Report Number
- 2647580-2013-00198
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 20, 2013
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO
- Product Code
- FZP
- PMA / PMN Number
- K853650
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: BREAST RECONSTRUCTION. ACCORDING TO THE REPORTER: WHEN THE SURGEON WENT TO CLIP THE VEIN, THE CLIP APPLIER WOULD NOT OPEN. A SECOND DEVICE WAS USED TO CLIP, THEN THE SURGEON CLIPPED THE VESSEL AND WENT TO REMOVE THE DEVICE; BUT THE JAWS LOCKED ON THE TISSUE. THE SURGEON WAS ABLE TO SAFELY RESECT A LITTLE BIT OF TISSUE AND REMOVE THE JAWS. ANOTHER DEVICE WAS OPENED. THERE WAS NO TISSUE DAMAGE, UNANTICIPATED BLOOD LOSS, UNANTICIPATED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION, CONVERSION TO OPEN PROCEDURE, OR EXTENDED OPERATING ROOM TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134224 | PREMIUM SURGICLIP II M-11.5 TITANIUM | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN, FORMERLY USSC PUERTO RICO | P2L0507X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |