BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM X 32CM STRYKEPROBE L-TIP

    MDR report key: 3142996 · Received June 3, 2013

    Report

    Report Number
    0002936485-2013-00241
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K963765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. VISUAL INSPECTION OF THE PROBE CONFIRMED THE PRESENCE OF A BENT L-TIP. VISUAL INSPECTION OF THE SHEATH CONFIRMED THE PRESENCE OF SLIGHT MELTING AT THE TIP. THE PROBABLE ROOT CAUSES FOR THE BENT L-TIP ARE:, USE ERROR AND/OR ,EXCESSIVE FORCE. THE PROBABLE ROOT CAUSES FOR THE MELTED SHEATH ARE: THE ELECTROCAUTERY PROBE IS NOT IN CONTACT WITH TISSUE, THE ELECTROCAUTERY PROBE IS ACTIVATED WHILE IRRIGATING OR ASPIRATING FLUID, THE ELECTROCAUTERY PROBE IS ACTIVATED WHILE THERE IS IRRIGATION FLUID IN THE CANNULA AND/OR THE TIP IS RETRACTED INTO THE SHEATH WHILE CURRENT IS ACTIVATED. 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 PROBE UNIT ARCED INAPPROPRIATELY WHILE HOOKED UP TO THE CAUTERY. FURTHER, THE UNIT IS BENT AND IT WAS ALLEGED THAT THE INSULATION MELTED DURING THE PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. A SHORT DELAY OF A COUPLE OF MINUTES WAS REPORTED WHILE ANOTHER UNIT WAS RETRIEVED TO FINISH THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROBE UNIT ARCED INAPPROPRIATELY WHILE HOOKED UP TO THE CAUTERY. FURTHER, THE UNIT IS BENT AND IT WAS ALLEGED THAT THE INSULATION MELTED DURING THE PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. A SHORT DELAY OF A COUPLE OF MINUTES WAS REPORTED WHILE ANOTHER UNIT WAS RETRIEVED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243070 5MM X 32CM STRYKEPROBE L-TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 1200379

    Patients

    Seq Age Sex Outcome Treatment
    1