BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIGATOR GRASPER

    MDR report key: 4042155 · Received June 30, 2014

    Report

    Report Number
    3007123990-2014-00004
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Manufacturer
    MINI LAP TECHNOLOGIES INC.
    Product Code
    KOG
    PMA / PMN Number
    K070686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE THE INSTRUMENT HAS NOT BEEN MADE AVAILABLE FOR MINI-LAP TECHNOLOGIES TO EVALUATE; THEREFORE, THE REPORTED FAILURE CANNOT BE CONFIRMED. A REVIEW OF THE DEVICE'S LOT HISTORY FOLDER WAS CONDUCTED AND NO ABNORMALITIES WERE NOTED AND SHOWED NO PREVIOUS RELATED NONCONFORMITIES. TO VERIFY THE STRENGTH AND RELIABILITY OF THE JAWS, MINILAP TECHNOLOGIES PERFORMED 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 POSITIONS 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 REPS TO INSTRUCT THE END USER TO BE COGNITIVE OF MANIPULATION AND TISSUE PLACED IN THE JAWS. A REVIEW OF THE INSTRUCTION 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 63 LBS AND 185 LBS AND RELIABILITY PASSED THREE TIMES). PROBABLE ROOT CAUSES FOR THE REPORTED FAILURE INVOLVING THIS DEVICE APPEARS RELATED TO MISUSE OR OVEREXERTION BY THE USER WITH EXCESSIVE TISSUE GRASPED IN THE JAWS. WE ARE UNABLE TO OBTAIN FURTHER DETAILS FROM THE USER. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT BASED ON PROBABLE ROOT CAUSE.

    Description of Event or Problem · 1

    PRONG OF MINILAP ALLIGATOR GRASPER BROKE OFF INSIDE PATIENT DURING A LAPCHOLE (REMOVAL OF GALLBLADDER). THE PIECE WAS RECOVERED. PER OP REPORT: IT WAS AT THIS POINT OF DISSECTION DURING RETRACTION OF THE GALLBLADDER THAT IT WAS NOTED THAT THE MINI GRASPER ON THE PROXIMAL END OF THE GALLBLADDER HAD FRACTURED WITH A SEGMENT OF THE GRASPER TIP EMBEDDED IN THE GALLBLADDER TISSUE. NO FURTHER DISSECTION WAS PERFORMED AND THE FRAGMENT WAS GRASPED WITH AN ATRAUMATIC GRASPER AND THEN BROUGHT OUT THROUGH THE UMBILICAL PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379416 ALLIGATOR GRASPER KOG MINI LAP TECHNOLOGIES INC. 0255000001 ML-000250

    Patients

    Seq Age Sex Outcome Treatment
    1