BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAWS "HIQ+" 5 X 330 MM, DEBAKEY

    MDR report key: 3062781 · Received April 11, 2013

    Report

    Report Number
    9610773-2013-00001
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 11, 2013
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MFR FOR EVALUATION BUT TO THE OLYMPUS DISTRIBUTOR (HINODE PLANT, JAPAN). DISTRIBUTOR'S EVALUATION REVEALED A DAMAGED CONNECTING SCREW AND CLEARLY VISIBLE CORROSION ON THE SITE OF FRACTURE. A PIECE OF THE CONNECTING SCREW WAS MISSING (SIZE: 1 MM X 2 MM). THE USER APPARENTLY APPLIED EXCESSIVE FORCE TO THE DEVICE AS HE REPORTEDLY USED IT LIKE A LEVER. THIS IS CASUAL FOR THE DAMAGED CONNECTING SCREW. IMPROPER REPROCESSING LED TO CORROSION AND THE SUBSEQUENT BREAKAGE OF THE DEVICE. THEREFORE THE CAUSE OF THE DEFECT WAS ATTRIBUTED TO ABNORMAL USE/OFF-LABEL USE. THERE WAS NO REPORT ABOUT PATIENT INJURY AND NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE OF THE COLON, THE TIP OF THE SUSPECT MEDICAL DEVICE BROKE APART AND THE FRAGMENTS FELL INTO THE PATIENT'S CAVITY. THE PHYSICIAN MANAGED TO RETRIEVE THE FRAGMENTS FROM THE PATIENT USING ANOTHER UNSPECIFIED FORCEPS. AFTERWARDS THE PROCEDURE WAS RESTARTED AND COMPLETED. AN X-RAY WAS TAKEN AND IT COULD BE CONFIRMED THAT NO FRAGMENTS REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154829 JAWS "HIQ+" 5 X 330 MM, DEBAKEY GRASPING FORCEPS GCJ OLYMPUS WINTER & IBE GMBH 087W08

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R