BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILAP ALLIGATOR GRASPER

    MDR report key: 2128779 · Received June 13, 2011

    Report

    Report Number
    3007123990-2011-00002
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MINI LAP TECHNOLOGIES INC.
    Product Code
    KOG
    PMA / PMN Number
    K070686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RECEIPT OF THIS REPORT ON (B)(4) 2011, (B)(4) OF MINI-LAP TECHNOLOGIES PERSONALLY SPOKE TO THE ATTENDING SURGEON, (B)(6). (B)(6) STATED THAT THIS WAS AN ELECTIVE CASE AND THE PATIENT HAD A LARGE AND DISTENDED GALLBLADDER WHEN HE TRIED TO MOVE THE GALLBLADDER HE PUSHED HARD WITH THE ALLIGATOR AND CAUSED THE JAWS TO BEND. (B)(6) THEN STATED THAT HE ATTEMPTED TO STRAIGHTEN THE JAWS UTILIZING ANOTHER INSTRUMENT AND WHILE HE WAS DOING THIS ONE OF THE JAWS BROKE. AS OF THIS DATE THE INSTRUMENT HAS NOT BEEN MADE AVAILABLE FOR MINI-LAP TECHNOLOGIES TO EVALUATE. MINI-LAP TESTED 10 JAWS IN A SIMULATED INSTRUMENT UTILIZING (B)(4) 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 (B)(4). 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 TO NOT ATTEMPT TO STRAIGHTEN BENT INSTRUMENT JAWS. ADDITIONAL DEVICE EVALUATION OF THE INSTRUMENT WILL BE COMPLETED AFTER RECEIPT OF THE INSTRUMENT AND THE RESULTS WILL BE FORWARDED. A REVIEW OF THE INSTRUCTION FOR USE BOOKLET STATES UNDER WARNINGS AND PRECAUTIONS ITEM #7, 8 TO AVOID DAMAGE TO THE INSTRUMENT TIPS (JAWS).

    Description of Event or Problem · 1

    A (B)(6) IN SURGERY FOR PROCEDURE WHEN THE MINI-LAP ALLIGATOR GRASPER BROKE INSIDE OF THE PATIENTS ABDOMEN. PHYSICIAN ATTEMPTED TO RETRIEVE THE PIECE OF THE GRASPER BUT WAS UNABLE TO LOCATE IT. X-RAY PERFORMED. INVESTIGATION ONGOING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINILAP ALLIGATOR GRASPER NONE KOG MINI LAP TECHNOLOGIES INC. 025500001 ML-000043

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR