BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2931950 · Received January 28, 2013

    Report

    Report Number
    3005099803-2013-00402
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CLIP ASSEMBLY WAS LOCATED INSIDE THE OVERSHEATH. THERE WERE NO ABNORMALITIES FOUND WITH THE OVERSHEATH. THE OVERSHEATH WAS PULLED BACK USING THE SHEATH GRIP AND THE CLIP ASSEMBLY WAS ACTUATED AND ABLE TO BE DEPLOYED. THE COMPLAINT DEVICE WAS FOUND TO BE WITHIN SPECIFICATIONS AND THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE RESOLUTION CLIP DEVICE WAS REMOVED FROM THE PACKAGING, "A COUPLE MM OF THE TIP OF THE PLASTIC SHEATH FELL OFF LEAVING A SHARP ENDED SHEATH." THE PROCEDURE WAS COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE RESOLUTION CLIP DEVICE WAS REMOVED FROM THE PACKAGING, "A COUPLE MM OF THE TIP OF THE PLASTIC SHEATH FELL OFF LEAVING A SHARP ENDED SHEATH." THE PROCEDURE WAS COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38338 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML000359C3

    Patients

    Seq Age Sex Outcome Treatment
    1