BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM L-TIP ELECTROSURGICAL PROBE (3BX)

    MDR report key: 3092599 · Received May 3, 2013

    Report

    Report Number
    0002936485-2013-00196
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 15, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    PMA / PMN Number
    K934094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. VISUAL INSPECTION CONFIRMED CRACKS ON THE HANDLE AND INSULATION. THE PROBABLE ROOT CAUSES ARE MANUFACTURING IN WHICH EXCESSIVE FORCE WAS APPLIED WHEN INSTALLING THE SHAFT ONTO THE HANDLE WITH THE ARBOR PRESS DURING ASSEMBLY PROCESS, IMPROPER STERILIZATION METHODS, NORMAL WEAR, AND/OR USER MISUSE. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION OF THE DEVICE WAS COMPROMISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION OF THE DEVICE WAS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193932 5MM, 33CM L-TIP ELECTROSURGICAL PROBE (3BX) LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE UNK 3

    Patients

    Seq Age Sex Outcome Treatment
    1