FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM
MDR report key: 1821712
·
Received August 31, 2010
Report
- Report Number
- 3005075853-2010-04981
- Event Type
- Malfunction
- Date Received
- August 31, 2010
- Date of Event
- August 5, 2010
- Report Date
- August 9, 2010
- 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LDG (LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY) PROCEDURE, THE CLIP WAS MALFORMED. AN ENDO CUTTER WAS USED AND IT LOCKED OUT AT THE FIRST FIRING. REINFORCEMENT MATERIAL WAS NOT USED. OTHER DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE CUSTOMER DISPOSED OF THE DEVICE, NO DEVICE WILL BE RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | G4RV08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |