BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIGATOR GRASPER

    MDR report key: 4042129 · Received June 30, 2014

    Report

    Report Number
    3007123990-2014-00005
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    December 30, 2013
    Manufacturer
    MINI LAP TECHNOLOGIES INC.
    Product Code
    KOG
    PMA / PMN Number
    K070686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    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). (B)(4). 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

    A FEMALE ADMITTED FOR SCHEDULED LAPAROSCOPIC CHOLECYSTECTOMY. DURING INITIAL NON-FORCEFUL GRASPING OF THE GALL BLADDER WITH THE ALLIGATOR GRASPER, A 9 MM X 2 MM PORTION OF THE TIP OF INSTRUMENT BROKE OFF. METICULOUS INSPECTION OF THE AREA WAS COMPLETED BY LAPAROSCOPE, WITH NO EVIDENCE OF THE FRAGMENT OF THE INSTRUMENT TO BE FOUND. AN INTRA-OPERATIVE FILM WAS OBTAINED BUT DID NOT DEFINITIVELY DETECT THE RETAINED FOREIGN BODY. THE PROCEDURE WAS COMPLETED AND THE PT WAS TRANSFERRED TO PACU WITH NO APPARENT ILL RESPONSE. SHE WAS DISCHARGED HOME FOLLOWING THE OUTPATIENT PROCEDURE AS EXPECTED. THIS INSTRUMENT WAS A NEW, DISPOSABLE ITEM. THE INSTRUMENT WAS NOT REPROCESSED. THE INSTRUMENT WAS PULLED FROM STOCK, INSPECTED FOR ANY DAMAGE OR INTEGRITY ISSUES TO THE PACKAGE AND REPORTEDLY HAD NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379430 ALLIGATOR GRASPER GRASPER KOG MINI LAP TECHNOLOGIES INC. 0255000001 ML-000219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention