FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX 5MM
MDR report key: 4192282
·
Received October 22, 2014
Report
- Report Number
- 3005075853-2014-07284
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- October 19, 2014
- Report Date
- October 21, 2014
- 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
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WOULD NOT CLOSE COMPLETELY AND CLIPS FELL OFF. THE CASE WAS COMPLETED WITH A SECOND DEVICE OF THE SAME PRODUCT CODE. NO BLEEDING OR LEAK WAS REPORTED AND NO PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 674246 | LIGAMAX 5MM | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | L4EU75 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |