BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIGATOR GRASPER

    MDR report key: 4014140 · Received June 30, 2014

    Report

    Report Number
    3007123990-2014-00011
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Manufacturer
    MINI-LAP TECHNOLOGIES
    Product Code
    KOG
    PMA / PMN Number
    K070686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RECEIPT OF THE INSTRUMENT THE BROKEN JAW WAS CONFIRMED AT MINI-LAP. A REVIEW OF THE DEVICES LOT HISTORY FOLDER WAS CONDUCTED AND NO ABNORMALITIES WERE NOTED AND SHOWED NO PREVIOUS RELATED NON-CONFORMANCES. A TEST OF THE INSTRUMENTS JAW WAS PERFORMED WERE THE UNBROKEN LEG WAS BENT BACK AND FORTH APPROXIMATELY 10 TIMES AND NO BREAKAGE OCCURRED. TO VERIFY THE STRENGTH AND RELIABILITY OF THE JAWS MINILAP TECHNOLOGIES PERFORMED ADDITIONAL TESTING VERIFICATION, 10 JAWS WERE TESTED IN A SIMULATED INSTRUMENT UTILIZING AN INSTRON MACHINE TO EVALUATE HOW MUCH FORCE IT WOULD TAKE TO BREAK THE JAWS, THE RESULTS SHOWED THAT DURING A STRAIGHT PULL THE JAWS YIELDED AT AN AVERAGE OF 43.89 LBS. PER LEG. ANOTHER TEST WAS PERFORMED ON 10 INSTRUMENTS BY BENDING EACH JAW 180 DEGREES FROM THEIR PRESENT POSITION TO DETERMINE HOW MANY BENDING CYCLES OF THE INDIVIDUAL JAW LEGS WOULD CAUSE THE DEVICE TO FAIL. THE TEN INSTRUMENTS (20) JAWS AVERAGED 14 BENDS PRIOR TO DEFORMATION (CRACKING, BREAKING, TWISTING). A CORRESPONDENCE WAS SENT TO OUR DISTRIBUTOR INSTRUCTING THEM TO CONTACT ALL THEIR SALES REPRESENTATIVES TO INSTRUCT THE END USER BE COGNITIVE OF THE END OF THE INSTRUMENT (JAWS) AND THE AMOUNT OF MANIPULATION AND TISSUE PLACED IN THE JAWS. A REVIEW OF THE INSTRUCTIONS FOR USE BOOKLET STATES UNDER WARNINGS AND PRECAUTIONS ITEM #7, 8 TO AVOID DAMAGE TO THE INSTRUMENT TIPS (JAWS). ADDITIONAL TESTING OF THE JAWS WAS CONDUCTED UNDER PROTOCOLS TR-0066 JAW FORCE TEST AND TR-0069 JAW RELIABILITY TEST, VERIFYING STRENGTH AND RELIABILITY (AVG 631 LBS AND 185LBS AND RELIABILITY PASSED THREE TIMES). PROBABLE ROOT CAUSES FOR THE REPORTED FAILURE INVOLVING THIS DEVICE APPEARS RELATED TO MISUSE OR OVER EXERTION BY THE USER WITH EXCESSIVE TISSUE GRASPED IN THE JAWS OR EXCESSIVE PRYING AND TWISTING DURING USE. WE ARE UNABLE TO OBTAIN FURTHER DETAILS FROM THE USER. THE COMPLAINT WILL BE CLOSED BASED ON PROBABLE ROOT CAUSE.

    Description of Event or Problem · 1

    AS REPORTED, THE SIDES OF THE TIP OF THE GATOR GRASPER BROKE OFF INSIDE THE PATIENT DURING A CASE. HOWEVER, THE SURGEON NOTICED IMMEDIATELY AND WAS ABLE TO RETRIEVE THE FALLEN PIECE AS SOON AS POSSIBLE. THEY OPENED ANOTHER GRASPER AND WERE ABLE TO FINISH THE CASE WITHOUT ANY MORE PROBLEM. THE DELAY WAS LESS THAN A FEW MINUTES AND THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379259 ALLIGATOR GRASPER KOG MINI-LAP TECHNOLOGIES 0255000001 ML-000205

    Patients

    Seq Age Sex Outcome Treatment
    1