FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1320724
·
Received February 24, 2009
Report
- Report Number
- 3005075853-2008-03788
- Event Type
- Malfunction
- Date Received
- February 24, 2009
- Date of Event
- November 27, 2008
- Report Date
- November 28, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 12/10/2008. NFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, AT THE TEST FIRING, THE CLIP WAS MALFORMED LIKE A TEARDROP, BUT THE NEXT THREE CLIPS WERE FORMED PROPERLY. AT FIRST, THE DEVICE WAS USED FOR CYSTIC DUCT WITHOUT ANY DIFFICULTIES. HOWEVER, SCISSORING OCCURRED WHEN THE DEVICE WAS USED FOR THE ARTERIA CYSTICA. THEN THE DEVICE WAS FIRED ON THE MALFORMED CLIP AGAIN, AND THE JAW COULD NOT BE OPENED. THE JAW WAS NOT ON THE BLOOD VESSEL, SO IT WAS RELEASED FORCIBLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM ENDO CLIP APPLIER | NONE | FZP | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |