FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1081082
·
Received July 21, 2008
Report
- Report Number
- 3005075853-2008-00597
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- June 23, 2008
- Report Date
- June 27, 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
- KS
- 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 NEPHRECTOMY PROCEDURE, THE DOCTOR APPLIED CLIP TO THE VESSEL, CLIP WAS MALFORMED. ITS FORMATION WAS LIKE A HOOK. VESSEL WAS NOT PERFECTLY CLIPPED. AFTER USING ONE CLIP, THE DOCTOR DID NOT USE AGAIN. SURGERY WAS PROLONGED FOR TEN MINUTES. UNKNOWN HOW CASE WAS COMPETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM ENDO CLIP APPLIER | FZP | ETHICON ENDO-SURGERY, LLC | NA | E9EP18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |