BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAWS INSERT, 330 MM WORKING LENGTH

    MDR report key: 2912912 · Received January 9, 2013

    Report

    Report Number
    9610773-2012-00241
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 28, 2012
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FCL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL BUT TO THE OLYMPUS DISTRIBUTOR (B)(6). AN INVESTIGATION OUTCOME IS NOT AVAILABLE YET. THEREFORE, THE EXACT CAUSE OF THE DEFECT (FALLEN OFF TIP) CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THERE WAS NO REPORT ABOUT PT INJURY AND THE FRAGMENT COULD BE RETRIEVED FROM THE PT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE OF LAPAROSCOPIC APPENDECTOMY, THE PHYSICIAN TRIED TO GRASP THE PT'S TISSUE WITH THE SUSPECT MEDICAL DEVICE (JAWS INSERT, 330 MM WORKING LENGTH, CROCEOLMI GRASPING FORCEPS) BUT COULDN'T MANAGE IT. THE PHYSICIAN WITHDREW THE DEVICE FROM THE PT AND CONFIRMED THAT THE TIP OF THE GRASPING FORCEPS WAS MISSING. HE TOOK AN X-RAY TO CHECK THE FRAGMENT, AND RETRIEVED IT FROM THE PT'S CAVITY (SIZE OF THE FRAGMENT: APPROX. 5 MM). JUDGING FROM THE MAIN BODY OF THE DEVICE AND THE RETRIEVED FRAGMENT, THE PHYSICIAN DETERMINED THAT NO FRAGMENT REMAINED INSIDE THE PT ANYMORE. THEN THE PHYSICIAN TOOK AN X-RAY AGAIN TO CONFIRM THAT NO FRAGMENT REMAINED INSIDE THE PT, JUST IN CASE. THE PHYSICIAN RE-STARTED THE PROCEDURE USING OTHER FORCEPS AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12121 JAWS INSERT, 330 MM WORKING LENGTH CROCEOLMI GRASPING FORCEPS FCL OLYMPUS WINTER & IBE GMBH 123W-0049

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other| R