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A Li Gator 360-010-001Recalls & reported problems

Genicon, Inc. · Class 1 · Implant

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00877972006343), received between Mar 6, 2020 and Sep 8, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Mechanical Jam2
  • Failure to Fire1
  • Mechanical Problem1
  • Misfire1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 8, 2020Mechanical Jam; Mechanical Jam

    DURING A LAP CHOLE WHEN SURGEON TRIED TO FIRE CLIP THE CLIPS JAMMED AND NO CLIPS DISCHARGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10504873 ↗
  • MalfunctionSep 8, 2020Mechanical Jam; Mechanical Jam

    THE DISPOSABLE CLIP APPLIER A LI-GATOR JAMMED AND THE DOCTOR COULD NOT CONTINUE TO USE THE CLIP APPLIER. THE EVENT WAS A COLELAP FOR A MALE PATIENT. IN THAT PROCEDURE THERE WAS NO INJURY TO THE PATIENT AND THERE WAS A DELAY IN PROCEDURE BUT THAT NOT IMPACT PATIENT SAFETY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10504866 ↗
  • MalfunctionAug 10, 2020Misfire; Failure to Fire; Misfire; Failure to Fire

    DOCTOR WAS DOING A CASE HE PRELOADED THE CLIPPER BEFORE USE AND FIE 1ST CLIP NOTHING CAME OUT, THEN HE TRIED 2ND TIME AND X2 CLIPS CAME OUT AND THE JAWS OF THE CLIP CUT OFF THE ARTERIES. CLIPPER WAS CHECKED AND "WAS STILL LOADED, THE HAND PIECE IS JAMMED."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10385394 ↗
  • MalfunctionMar 6, 2020Mechanical Problem; Mechanical Problem

    THIS REPORT SUMMARIZES A PREVIOUSLY UNREPORTED MALFUNCTION. THE DISTRIBUTOR REPORTED THAT THE DOCTOR WAS UNABLE TO CLIP THE VESSEL AND DUCT (OF A PATIENT AND DURING SURGERY) DUE TO STAPLES JAMMING IN THE CLIP APPLIER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9803325 ↗

Other Applier, Surgical, Clip devices

All Applier, Surgical, Clip devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.