FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM
MDR report key: 2043009
·
Received April 7, 2011
Report
- Report Number
- 3005075853-2011-01391
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 7, 2011
- Report Date
- March 15, 2011
- 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). JAW.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, ON THE SECOND CLIP THE DEVICE LOCKED DOWN ON THE CYSTIC DUCT. THEY ATTEMPTED TO OPEN WITH THE HANDLE BUT IT WOULD NOT OPEN. THE SURGEON USED A GRASPER TO EASE THE DEVICE OFF THE TISSUE. ONCE REMOVED, THERE WAS NO TISSUE TRAUMA NOTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | G4UH64 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |