FDA Adverse Event
Injury
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1161679
·
Received September 16, 2008
Report
- Report Number
- 3005075853-2008-01722
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- May 23, 2008
- Report Date
- September 10, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 LAP SPLENECTOMY PROCEDURE, IT IS REPORTED THAT THE DEVICE WAS FIRED ONCE. ON THE 2ND FIRING THE INSTRUMENT WOULD NOT FIRE AND THE JAWS WOULD NOT OPEN. THEY HIT THE INSTRUMENT AND THEN IT OPENED. THERE IS MENTION THAT THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE, BUT THERE IS NO INDICATION AS TO WHY THIS WAS DONE. 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 | FZP | ETHICON ENDO-SURGERY, LLC | NA | E4L83X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |