BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO¿

    MDR report key: 6156768 · Received December 8, 2016

    Report

    Report Number
    3005099803-2016-03802
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    August 15, 2016
    Report Date
    November 22, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EVALUATION OF THE RETURNED CAPIO DEVICE FOUND NO VISUAL FAILURES. FUNCTIONAL EVALUATION FOUND THAT THE DEVICE COULD BE ACTUATED WITH A TEST SUTURE AND THE NEEDLE ENTERED THE SLOT WITHOUT ANY ISSUES. AFTER THIS TEST, THE SUTURE WAS UNLOADED FROM THE DEVICE AND WAS STILL IN GOOD CONDITION. THE RETURNED DEVICE PRESENTED NO VISUAL OR FUNCTIONAL ISSUE. THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. A DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE USER MEDWATCH REPORT NUMBER IS MW5065808.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPC, PACKAGED WAS USED DURING THE VAGINAL VAULT SUSPENSION PROCEDURE ON (B)(6) 2016. DURING THE PROCEDURE, INSIDE THE PATIENT, ON THE FIRST SUTURE THROW, THE CAPIO DEVICE DID NOT FIRE PROPERLY. AS A RESULT, THE SUTURE NEEDLE WAS BROKEN INSTEAD OF CATCHING IN THE CAPIO CAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806977 CAPIO¿ LAPAROSCOPE, GENERAL & PLASTIC SURGERY FHQ BOSTON SCIENTIFIC - MARLBOROUGH M0068311251 18744758

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR