BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO¿ SLIM

    MDR report key: 6115857 · Received November 20, 2016

    Report

    Report Number
    3005099803-2016-03484
    Event Type
    Malfunction
    Date Received
    November 20, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FHQ
    UDI-DI
    08714729842224
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO¿ SLIM WAS USED DURING AN ANTERIOR & POSTERIOR VAGINAL REPAIR WITH SACROSPINOUS FIXATION PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CAPIO CARRIER WAS UNABLE TO RETRACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO¿ SLIM 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766679 CAPIO¿ SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0068318261 0019437992 08714729842224

    Patients

    Seq Age Sex Outcome Treatment
    1