FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM
MDR report key: 2021738
·
Received March 17, 2011
Report
- Report Number
- 3005075853-2011-01053
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- February 17, 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
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE CLIPS MALFORMED DURING THE FIRST FIRING SEQUENCE. DOUBLE UP ON CLIPS ALSO OCCURRED DURING SUBSEQUENT FIRING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | G4U69L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |