FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP** CLIPS/CARTRIDGE
MDR report key: 3120409
·
Received May 20, 2013
Report
- Report Number
- 3005075853-2013-02419
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 24, 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
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: MULTIPLE REQUESTS FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LIVER RESECTION CASE, THE CLIPS WERE APPLIED TO TISSUE BUT ONCE APPLIED THEY SIMPLY FELL OFF THE TISSUE. THIS ISSUE HAS OCCURRED IN THE PAST AT THIS HOSPITAL. THE SURGEON USED A COMPETITOR¿S PRODUCT TO COMPLETE THE OPERATION AND NO ADVERSE EVENT OCCURRED WITH THE PATIENT. NO LOT NUMBER WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222477 | LIGACLIP** CLIPS/CARTRIDGE | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |