BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8010047-2015-00056

    MDR report key: 4456745 · Received January 19, 2015

    Report

    Report Number
    8010047-2015-00056
    Event Type
    Malfunction
    Date Received
    January 19, 2015
    Date of Event
    December 22, 2014
    Report Date
    December 23, 2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SAME LOT, NOTHING ABNORMAL DETECTED. THE EXACT CAUSE OF THIS PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED SINCE THE SUBJECT DEVICES WERE DISCARDED BY THE CUSTOMER. THIS REPORT WILL BE SUPPLEMENTED IF ANY IMPORTANT ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THAT INTENDED TO REMOVE A LARGE RECTAL POLYP, THE CUSTOMER TRIED TO CLIP THE BLEED. THE CUSTOMER USED TWO SUBJECT DEVICES, BUT BOTH OF THEM FAILED TO CLIP PROPERLY. ONE OF THE TWO DEVICES HAD THE PHENOMENON THAT ONLY ONE ARM OF CLIP HAD BEEN EXTENDED FROM THE SHEATH. NO CLIPS FELL INTO THE PATIENT'S BODY AND THE CUSTOMER COMPLETED THIS PROCEDURE USING A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 MFR #8010047-2015-00057, MODEL #HX-201UR-135L| LOT #42V