BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR¿

    MDR report key: 2914759 · Received January 14, 2013

    Report

    Report Number
    3005099803-2013-00256
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    October 1, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: WIRE NOT "FREE OF SHARP." THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SMALL OVAL SNARE AND A CAPTIVATOR MEDIUM OVAL SNARE WERE INSPECTED ON (B)(4) 2012.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES. MANUFACTURER REPORT # 3005099803-2013-00256 MANUFACTURER REPORT # 3005099803-2013-00257 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR SMALL OVAL SNARES WERE INSPECTED ON (B)(4) 2012. ACCORDING TO THE COMPLAINANT, FIVE FAILURES WERE NOTED: THE TIP OF THE WIRE WAS NOT "FREE OF SHARP," "THE SHEATH [WAS] NOT STIFF ENOUGH," SHARP EDGES WERE FOUND ON "THE FINGER RING OF THE HANDLE AND O-RING OF THE HANDLE," "THE SNARE HANDLE FOUND SOME FLUID LEAKAGE TO THE HANDLE," AND "THE FITTING BETWEEN [THE ERBE ACTIVE] CORD [...] AND THE DISPOSABLE ENDOSCOPIC SNARE [WAS] NOT WELL FIT." AS THE ISSUE WAS NOTED DURING INSPECTION, NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES. MANUFACTURER REPORT # 3005099803-2013-00256 MANUFACTURER REPORT # 3005099803-2013-00257 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR SMALL OVAL SNARES WERE INSPECTED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, FIVE FAILURES WERE NOTED: THE TIP OF THE WIRE WAS NOT "FREE OF SHARP," "THE SHEATH [WAS] NOT STIFF ENOUGH," SHARP EDGES WERE FOUND ON "THE FINGER RING OF THE HANDLE AND O-RING OF THE HANDLE," "THE SNARE HANDLE FOUND SOME FLUID LEAKAGE TO THE HANDLE," AND "THE FITTING BETWEEN [THE ERBE ACTIVE] CORD [...] AND THE DISPOSABLE ENDOSCOPIC SNARE [WAS] NOT WELL FIT." AS THE ISSUE WAS NOTED DURING INSPECTION, NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21589 CAPTIVATOR¿ SMALL OVAL - STIFF FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562301 15398631

    Patients

    Seq Age Sex Outcome Treatment
    1