BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX LOCKING DEVICE AND BIOPSY CAP

    MDR report key: 6124573 · Received November 23, 2016

    Report

    Report Number
    3005099803-2016-03541
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    UDI-DI
    08714729296614
    PMA / PMN Number
    K010610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX LOCKING DEVICE AND BIOPSY CAP WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE STYLET OF THE CANNULA OR SPHINCTEROTOME WAS USED TO PUNCTURE THE BIOPSY CAP. HOWEVER; THE STYLET EXTENDED TOO FAR PUSHING THE SPONGE CAUSING IT TO DETACH FROM THE CAP. REPORTEDLY, THE SPONGE WAS STUCK IN THE SCOPE THUS A REGULAR EGD SCOPE WAS USED TO VISUALIZE THE ANATOMY. DUE TO A LARGE TUMOR, CANNULATION WAS UNSUCCESSFUL BUT THE PROCEDURE WAS COMPLETED BY TAKING A COUPLE OF BIOPSY SAMPLE. 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
    777152 RX LOCKING DEVICE AND BIOPSY CAP ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - SPENCER M00545261 19422061 08714729296614

    Patients

    Seq Age Sex Outcome Treatment
    1