FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP EXTRA TITANIUM CLIPS
MDR report key: 3133134
·
Received May 29, 2013
Report
- Report Number
- 3005075853-2013-02610
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- April 24, 2013
- Report Date
- May 8, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- FZP
- PMA / PMN Number
- K830503
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- 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 CARDIOVASCULAR PROCEDURE, THE CLIPS FALL APART OR BENDS WHEN THE CLIP HOLDER IS INSERTED INTO THE CARTRIDGE. ANOTHER CARTRIDGE WAS OPENED AND THE CASE WAS ABLE TO BE COMPLETED WITHOUT FURTHER ISSUES. NO ADVERSE CONSEQUENCES REPORTED. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234339 | LIGACLIP EXTRA TITANIUM CLIPS | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CLIP HOLDER |