BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 3770253 · Received March 7, 2014

    Report

    Report Number
    8010047-2014-00102
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 24, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE CUTTING KNIFE WAS MELTED AND BROKEN. IN ADDITION, IT WAS BURNT. ALSO AS THE RESULT OF CHECKING THE MFG RECORD OF THE SAME LOT, NOTHING ABNORMAL DETECTED. OMSC ASSUMES THAT THE LOCAL CUTTING WIRE BECAME EXTREMELY HOT SINCE THE LENGTH OF THE CONTACT BETWEEN THE CUTTING KNIFE AND TISSUE WAS TOO SHORT AND IT CAUSED THE BREAKAGE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING COLON ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), THE BREAKAGE OF THE DISTAL END OF THE DEVICE OCCURRED AND CAME OFF TEN MINUTES LATER AFTER THE PROCEDURE WAS STARTED. THE DOCTOR COMPLETED THE PROCEDURE BY USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139559 SINGLE USE ELECTROSURGICAL KNIFE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORPORATION KD-612L K3Z02

    Patients

    Seq Age Sex Outcome Treatment
    1