BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3800950 · Received May 8, 2014

    Report

    Report Number
    0001056128-2014-00054
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    PMA / PMN Number
    K111600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATIONS. VISUAL INSPECTION REVEALED BIOLOGICAL MATERIAL ON THE HANDLE AND JAWS OF THE DEVICE; EVIDENCE THAT IT WAS CLINICALLY USED. THUMB BUTTON FEEDBACK WAS ACCEPTABLE AS IT WAS ABLE TO DEPRESS THE PRESSURE PAD ON THE MEMBRANE SWITCH AND EXHIBITED A TACTILE CLICK; AND THE PRESSURE PAD DISENGAGED WHEN RELEASED. THE JAW FUNCTIONALITY WAS TESTED AND CONFIRMED TO BE ACCEPTABLE AS THE DEVICE WAS ABLE TO ACTUATE, LOCKED/UNLOCK MULTIPLE TIMES. A CONTINUITY TEST WAS PERFORMED ON THE DEVICE AND FOUND TO HAVE PASSED, AS NO OPEN OR SHORT CIRCUIT CONDITIONS WERE IDENTIFIED WITHIN THE ELECTRICAL PATHS. THE DEVICE WAS THEN TESTED BY GRASPING MATERIAL TO BE ENERGIZED FOR TWO CYCLES. THE DEVICE WAS RECOGNIZED BY THE GENERATOR AND THE DEFAULT NUMBER OF POWER BARS WERE DISPLAYED. HOWEVER, WHEN THE THUMB BUTTON OR FOOT PEDAL WERE PRESSED, THE ENERGY PLATFORM REPEATEDLY EMITTED AN ALARM/ERROR DURING DEVICE TESTING. THE RECEIVED DEVICE WAS FURTHER INSPECTED AND REVEALED A DAMAGED PIN CONNECTOR, WHICH ATTRIBUTED TO THE DEVICE NOT CONNECTING TO THE GENERATOR. THE PIN WAS NOT BOWING OUT AND AS A RESULT WOULD NOT MAKE PROPER CONTACT WITH THE GENERATOR. THE REPORTED ISSUE WAS SUBSTANTIATED AS THE RETURNED DEVICE WAS FOUND TO HAVE A DAMAGED PIN ON THE CONNECTOR OF THE CORD, AND WAS NOT ABLE TO PASS ENERGY FROM THE GENERATOR. IN ADDITION, THE DEVICE DID NOT REVEAL ANY ISSUES WITH THE MECHANICAL FUNCTIONS. A POTENTIAL CAUSE FOR THE DEVICE BEING DEFECTIVE, IS THAT THE DEVICE WAS CONNECTED / USED IN A WAY THAT CAUSED DAMAGE TO THE PIN ON THE CONNECTOR OF THE POWER CORD (E.G., NOT INSERTING THE LIGASMARTTM CONNECTOR FIRMLY/COMPLETELY; IMPROPER CONNECTION, USE WITH AN INCOMPATIBLE ACCESSORY / GENERATOR OR UNKNOWN END USER TECHNIQUE.) THE INSTRUCTIONS FOR USE (IFU) REPROCESSED HAND ACTIVATED SEALER/DIVIDER STATES: ¿VERIFY COMPATIBILITY OF ALL INSTRUMENTS AND ACCESSORIES BEFORE THE BEGINNING OF THE PROCEDURE.¿ ¿WITH THE BARCODE ON THE LIGASMARTTM CONNECTOR FACING UP, FIRMLY INSERT IT INTO ONE OF THE HAND ACTIVATED SEALER DIVIDER RECEPTACLES UNDER THE RIGHT LIGASURE TOUCH SCREEN ON THE ENERGY PLATFORM FRONT PANEL.¿ ¿PRIOR TO USAGE, EXAMINE THE INSTRUMENT AND CORDS FOR BREAKS, CRACKS, NICKS, OR OTHER DAMAGE. FAILURE TO OBSERVE THIS CAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR SURGICAL TEAM OR CAUSE DAMAGE TO THE INSTRUMENT. DO NOT USE IF DAMAGED.¿ ¿THE REPROCESSED LIGASURE IMPACT¿ LF4200 (HEREINAFTER HAND ACTIVATED SEALER/DIVIDER) IS AN INSTRUMENT THAT WORKS EXCLUSIVELY WITH THE FORCE TRIAD¿ ENERGY PLATFORM UTILIZING THE TISSUEFECT¿ SENSING TECHNOLOGY THAT PRECISELY MANAGES ENERGY DELIVERY FOR CONSISTENT CONTROLLED TISSUE EFFECTS.¿ ¿BEFORE USING, INSPECT ALL CONNECTIONS TO THE ENERGY PLATFORM AND ALL INSTRUMENTS AND ACCESSORIES. IMPROPER CONNECTION MAY RESULT IN ARCS, SPARKS, ACCESSORY MALFUNCTION, OR UNINTENDED SURGICAL EFFECTS.¿ ¿FOR USE WITH A MAXIMUM VOLTAGE OF 288 VOLTS (PEAK).¿ THE DEVICE HISTORY RECORDS (DHR) FOR THE COMPLAINT DEVICE INDICATES THAT THE DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THIS REPORT WAS FILED DUE TO THE EVENT BEING INHERENTLY DANGEROUS. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS NOT YET BEEN COMPLETED FOR THIS EVENT. A SUPPLEMENTAL WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE LIGASURE IMPACT WOULD NOT CAUTERIZE, IT JUST BEEPED." NO ADVERSE CONSEQUENCE OR PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE LIGASURE IMPACT WOULD NOT CAUTERIZE, IT JUST BEEPED." NO ADVERSE CONSEQUENCE OR PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277537 NA ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF4200 2791222

    Patients

    Seq Age Sex Outcome Treatment
    1