BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW HOT SINGLE-USE BIOPSY FORCEPS

    MDR report key: 2432263 · Received January 30, 2012

    Report

    Report Number
    3005099803-2012-00317
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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.A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.(B)(4)

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-00315, 3005099803-2012-00316, 3005099803-2012-00317, AND 3005099803-2012-00318 ADDRESS THESE DEVICES.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS WERE USED DURING A COLONOSCOPY PROCEDURE ON (B)(6), 2012.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ACTIVE CORD WAS CONNECTED TO THE FORCEPS DEVICE, BUT IT DETACHED FROM THE CONNECTING PIN. THE USER FELT THAT THE CONNECTOR PORT WAS TO LARGE WHICH LED TO THE DETACHMENT. THE DEVICE WAS WITHDRAWN FROM THE PATIENT AND THE PROCEDURE WAS CONTINUED WITH ANOTHER FORCEPS DEVICE. HOWEVER, THE SAME ISSUE RECURRED WITH THE NEXT THREE DEVICES. THE PROCEDURE WAS COMPLETED WITH A FIFTH RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS 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
    1 RADIAL JAW HOT SINGLE-USE BIOPSY FORCEPS FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00515500 14761531

    Patients

    Seq Age Sex Outcome Treatment
    1