BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKED SPRINGTIP GW

    MDR report key: 3112075 · Received February 17, 2006

    Report

    Report Number
    1223688-2006-00029
    Event Type
    Malfunction
    Date Received
    February 17, 2006
    Date of Event
    July 1, 2005
    Report Date
    January 19, 2006
    Manufacturer
    CONMED ENDOSCOPIC TECHNOLOGIES
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED, USER RELATED. TWO DEVICES WERE RETURNED AND IT WAS UNK WHICH DEVICE BELONGED TO THIS COMPLAINT THEREFORE BOTH DEVICES WERE EVALUATED. AS THE DEVICES WERE FOUND TO BE SEVERELY KINKED ALONG THEIR ENTIRE LENGTH AND THE PREVIOUS USES OF THE DEVICES OCCURRED WITHOUT INCIDENT, ALL OF THE DAMAGE MUST HAVE OCCURRED DURING THE LAST AND FINAL USE OF THE DEVICES. THE EVIDENCE SUGGEST THAT THE USER'S INSERTION TECHNIQUE PLACED EXCESSIVE LATERAL FORCE ON THE WIRE/SPRING TIPS DURING INSERTION AND/OR REMOVAL FROM THE SCOPE AT IT'S POINT OF ENTRY. THE DEVICES MAY HAVE BEEN USED BEYOND THEIR USEFUL LIFESPAN. THE LOT NUMBER OF THE DEVICE IS UNK, HOWEVER, A DHR REVIEW OF THE LAST TWO LOT NUMBERS OF THIS DEVICE SHIPPED TO THE CUSTOMER REVEALED NO DISCREPANCIES WITH EITHER LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    THE GUIDEWIRE KINKED AS IT WAS BEING INSERTED INTO THE ENDOSCOPE. PER THE USER, THE DEVICE HAD BEEN USED APPROX FIVE TIMES BEFOREHAND WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARKED SPRINGTIP GW GUIDEWIRE KOG CONMED ENDOSCOPIC TECHNOLOGIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK