BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO? SLIM

    MDR report key: 4919484 · Received July 16, 2015

    Report

    Report Number
    3005099803-2015-02005
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    April 10, 2015
    Report Date
    June 19, 2015
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED CAPIO SLIM DEVICE REVEALED THAT THE DEVICE HAS THE CARRIER BROKEN AT THE CRIMPED SECTION AND TWO RIVETS ARE LOOSE. IT WAS DETERMINED THAT THE SUPPLIER USED MOLDS WORN OUT AND IN BAD CONDITION. THIS WAS LIKELY DUE TO A SUPPLIER MANUFACTURING ISSUE. THE SUPPLIER HAS SINCE COMPLETED AN INVESTIGATION TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT ANOTHER COMPLAINT HAS BEEN REPORTED FOR THE SAME LOT NUMBER BY A DIFFERENT CUSTOMER DUE TO A DIFFERENT REASON.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM DEVICE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE NEEDLE WOULD NOT DEPLOY AND WOULD NOT RECOIL. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: THE DEVICE HAS THE CARRIER BROKEN AT THE CRIMPED SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463184 CAPIO? SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0068318250 17432283

    Patients

    Seq Age Sex Outcome Treatment
    1