BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO¿ SLIM

    MDR report key: 5993947 · Received October 3, 2016

    Report

    Report Number
    3005099803-2016-02997
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 8, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED CAPIO¿ SLIM REVEALED THAT THE DEVICE HAS THE CAGE DAMAGED. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS HANDLING DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4) CARRIER WOULD NOT RETRACT. 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 USED DURING A SACROSPINOUS FIXATION PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE CAPIO CARRIER GOT STUCK IN THE CAPIO CAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER A CAPIO SLIM. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM WAS USED DURING A SACROSPINOUS FIXATION PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE CAPIO CARRIER GOT STUCK IN THE CAPIO CAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER A CAPIO SLIM. 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
    646807 CAPIO¿ SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0068318261 0018915563

    Patients

    Seq Age Sex Outcome Treatment
    1