BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 4252066 · Received November 14, 2014

    Report

    Report Number
    0002936485-2014-00922
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 27, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CONDITION COULD NOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED FOR EVALUATION. THE MOST PROBABLE ROOT CAUSES FOR ¿UNINTENDED ENERGY DELIVERED¿ CONDITION ARE: 1. PROBE SHORT ¿ IF THERE IS A MANUFACTURING RELATED DEFECT CONSEQUENTLY CAUSING AN INTERNAL SHORT, THE CONSOLE WOULD DETECT IT AND TRIGGER AN ERROR CODE. NO ERROR CODE WAS REPORTED WHICH WOULD HELP IDENTIFY THE POSSIBLE CONTRIBUTOR FOR THE REPORTED FAILURE. 2. BUTTON STUCK ON THE FIRING POSITION ¿ A CONDITION OF BUTTON BEING MECHANICALLY STUCK ON THE FIRING POSITION COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THIS CONDITION IS MOSTLY LIKELY TO BE CAPTURED BY THE USER IF IT OCCURS. 3. FLUID INGRESS - FLUID INGRESS INTO THE HANDLE MAY LEAD TO A MALFUNCTION AND/OR CONTINUOUS ACTIVATION BY THE CURRENT PATH CREATED THROUGH THE SALINE WATER, HOWEVER SINCE THE UNIT WAS NOT RETURNED, IT CANNOT BE CONFIRMED IF THERE WAS FLUID INGRESS AND/OR THE POINT OR SOURCE OF THE FLUID INGRESS INSIDE THE HANDLE. BASED ON PREVIOUS COMPLAINT HISTORY, THE MOST PROBABLE FLUID INGRESS SOURCES ARE: - THE UNIT, WHILE IN USE, IS SUBMERGED IN THIS FLUID POCKET OR SURGICAL AREA COVER USED TO CONTAIN FLUIDS IN A POCKET DURING SURGERY, WATER INGRESSION CAN BE OBSERVED WHICH MAY CAUSE THE UNIT TO CONTINUOUSLY ACTIVATE. - CUTTING THE SUCTION TUBE OF THE SERFAS SUCTION PROBES BEFORE USE DURING SURGERY CONSEQUENTLY RESULTING IN FLUIDS BACK FLOWING INSIDE THE HANDLE. 4. BUTTON INADVERTENTLY PRESSED ¿ BASED ON THE EVENT DESCRIPTION AND INFORMATION PROVIDED, THE POSSIBILITY OF THE USER INADVERTENTLY PRESSING THE BUTTONS CAN BE RULED OUT AS A POSSIBLE CONTRIBUTOR IN THIS CASE. 5. DAMAGED INSULATION - NO INSULATION AND/OR PHYSICAL DAMAGE OF THE PROBE WAS REPORTED THEREFORE, THIS POSSIBLE CONTRIBUTOR CAN BE RULED OUT. 6. PROBE BENDER USED TO BEND A NON-BENDABLE PROBE ¿ NO INFORMATION WAS PROVIDED REGARDING THE POSSIBILITY OF BENDING THIS NON-BENDABLE PROBE. 7. CONSOLE ERROR - A CONSOLE RELATED FAILURE AS WELL AS A POSSIBLE FOOT SWITCH RELATED FAILURE (IF USED) CANNOT BE RULED OUT. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THEREFORE THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CONTINUOUS ACTIVATION, BUT THE UNIT WAS NOT NEAR THE PATIENT OR SURGEON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CONTINUOUS ACTIVATION, BUT THE UNIT WAS NOT NEAR THE PATIENT OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737905 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 14113AE2

    Patients

    Seq Age Sex Outcome Treatment
    1