FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1112790
·
Received August 12, 2008
Report
- Report Number
- 3005075853-2008-01134
- Event Type
- Malfunction
- Date Received
- August 12, 2008
- Date of Event
- July 17, 2008
- Report Date
- August 1, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SYMPATHECTOMY PROCEDURE, THE SURGEON PLACED A CLIP ON A NERVE AND THE CLIP APPLIER WOULD NOT RELEASE CLIP. SURGEON OPENED A NEW DEVICE AS SECOND APPLIER AFTER FIRST ONE LOCKED. THIS DEVICE RELEASED CLIPS BUT WOULD NOT CLOSE THEM. AN UNK AMOUNT OF BLEEDING WAS REPORTED, AS A RESULT OF THIS EVENT, BUT NO TRANSFUSION WAS REQUIRED. THE PROCEDURE WAS FINISHED WITH REUSEABLE APPLIER. THE PROCEDURE WAS EXTENDED BY 50 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM ENDO CLIP APPLIER | FZP | ETHICON ENDO-SURGERY, LLC | NA | E4KM4U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |