BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO¿ SLIM

    MDR report key: 4974278 · Received August 5, 2015

    Report

    Report Number
    3005099803-2015-02222
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED CAPIO SLIM REVEALED THAT THE ORIGINAL BOX WAS SEALED AND DAMAGED. HOWEVER, THE STERILITY BARRIER WAS NOT COMPROMISED. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS UNDETERMINABLE. A COMPLAINT WITH A ROOT CAUSE CLASSIFICATION OF UNDETERMINABLE INDICATES REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM WAS RECEIVED IN THE FACILITY ON JULY 13, 2015. ACCORDING TO THE COMPLAINANT, THE DEVICE PACKAGING WAS DAMAGED AND THE REPORTER WAS UNABLE TO CONFIRM WHETHER OR NOT THE STERILE BARRIER WAS COMPROMISED. THERE WAS NO PROCEDURE INVOLVED AND THE DEVICE WAS NOT USED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM WAS RECEIVED IN THE FACILITY ON (B)(6), 2015. ACCORDING TO THE COMPLAINANT, THE DEVICE PACKAGING WAS DAMAGED AND THE REPORTER WAS UNABLE TO CONFIRM WHETHER OR NOT THE STERILE BARRIER WAS COMPROMISED. THERE WAS NO PROCEDURE INVOLVED AND THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514992 CAPIO¿ SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0068318250 17991696

    Patients

    Seq Age Sex Outcome Treatment
    1