BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHINCTEROTOME

    MDR report key: 2142987 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02292
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K973826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF; 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEEDLEKNIFE RX SPHINCTEROTOME WAS USED DURING A SPHINCTEROTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE SPHINCTEROTOMY THE PHYSICIAN FACED DIFFICULTIES TO CUT WITH NEEDLEKNIFE AND DURING WITHDRAWAL OF THE NEEDLEKNIFE FROM THE GUIDEWIRE, THE DEVICE BECAME STUCK. THE PHYSICIAN REMOVED THE NEEDLEKNIFE AND OBSERVED THAT THE COATING/RESIN HAD PEELED FROM THE DEVICE. NO PARTS DETACHED INSIDE THE PATIENT. THE SPHINCTEROTOMY WAS COMPLETED WITH ANOTHER NEEDLEKNIFE RX SPHINCTEROTOME. 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 OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545840 13992705

    Patients

    Seq Age Sex Outcome Treatment
    1