BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA

    MDR report key: 8597918 · Received May 9, 2019

    Report

    Report Number
    0001056128-2019-00026
    Event Type
    Death
    Date Received
    May 9, 2019
    Date of Event
    April 3, 2019
    Report Date
    December 3, 2020
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    UDI-DI
    07613327346244
    PMA / PMN Number
    K161693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11/18/2020, STRYKER SUSTAINABILITY SOLUTIONS BECAME AWARE THAT MDR SECTION B2. (OUTCOMES ATTRIBUTED TO AE) WAS NOT COMPLETED FOR THIS MDR. THIS SUPPLEMENTAL MDR SERVES TO PROVIDE THIS INFORMATION. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE HARMONIC SCALPEL (HARH45) FAILED, IT WAS NOT SEALING PROPERLY. THIS WAS NOTED POST OPERATION. IT WAS STATED THE VESSEL WAS FULLY SEALED DURING THE BARIATRIC PROCEDURE, THE PATIENT WAS RELEASED, BUT CAME BACK AND THE VESSEL WAS BLEEDING AND THE PATIENT EXPIRED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. THE FACILITY STATED THEY ARE WORKING WITH THEIR RISK MANAGEMENT TEAM. THE DEVICE IS BEING HELD BY THE FACILITY. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, INSPECTION WAS UNABLE TO BE PERFORMED. A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE LOT NUMBER AND/OR SERIAL NUMBER WAS NOT REPORTED. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE: USER EXPECTATION OF ADAPTIVE TISSUE TECHNOLOGY FUNCTIONALITY; USER SELECTS IMPROPER MIN SETTINGS ON GENERATOR; ANCILLARY EQUIPMENT ISSUES (E.G. GENERATOR, HANDPIECE, AND/OR ADAPTOR); USER MISINTERPRETS GENERATOR SIGNAL; TISSUE ACCUMULATION BETWEEN THE BLADE AND SHAFT. THE INSTRUCTIONS FOR USE (IFU) STATE: CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. CLAMPING THE TISSUE PAD AGAINST THE ACTIVE BLADE WITHOUT TISSUE ON THE FULL LENGTH OF THE BLADE WILL RESULT IN HIGHER BLADE, CLAMP ARM AND DISTAL SHAFT TEMPERATURES AND CAN RESULT IN POSSIBLE DAMAGE TO THE INSTRUMENT. IF THIS OCCURS, THERE MAY BE AN INSTRUMENT FAILURE, AND THE GENERATOR TOUCHSCREEN DISPLAYS A TROUBLESHOOTING MESSAGE. INCIDENTAL AND PROLONGED ACTIVATION AGAINST SOLID SURFACES, SUCH AS BONE, MAY RESULT IN BLADE HEATING AND SUBSEQUENT BLADE FAILURE, AND SHOULD BE AVOIDED. IF ACTIVATION IS UNINTENTIONALLY STOPPED WHILE SEALING, MAINTAIN JAW CLOSURE AND REACTIVATE. THE INSTRUMENT CAN BE USED FOR DISSECTION, GRASPING, COAGULATION, AND CUTTING BETWEEN THE BLADE AND CLAMP ARM. NOTE: TO ACHIEVE COMPLETE SEALING, THE TRIGGER SHOULD BE FULLY CLOSED AND THE VESSEL FULLY CONTAINED BETWEEN CLAMP ARM AND BLADE OF DEVICE. AN AUDIBLE AND TACTILE "CLICK" INDICATES FULL TRIGGER CLOSURE. TO ACHIEVE FULL CLOSURE OF THE JAWS OF THE DEVICE, SQUEEZE THE PLASTIC TRIGGER UNTIL YOU FEEL IT STOP AGAINST THE PLASTIC HANDLE (PLASTIC TO PLASTIC). IF FULL TRIGGER CLOSURE IS RELEASED PRIOR TO OR DURING ACTIVATION ON TISSUE, AN AUDIBLE AND TACTILE "CLICK" IS EVIDENT. INCREASE GRIP FORCE UNTIL FULL TRIGGER CLOSURE IS ACHIEVED. FOR OPTIMAL PERFORMANCE AND TO AVOID TISSUE STICKING, CLEAN THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL END OF THE SHAFT THROUGHOUT THE PROCEDURE BY ACTIVATING THE INSTRUMENT TIP IN SALINE. NOTE: DO NOT TOUCH THE INSTRUMENT TO METAL WHILE ACTIVATED. NOTE: DO NOT CLEAN THE BLADE TIP WITH ABRASIVES. IT CAN BE WIPED WITH A MOIST GAUZE SPONGE TO REMOVE TISSUE, IF NECESSARY. IF TISSUE IS STILL VISIBLE IN THE CLAMP ARM, USE HEMOSTATS TO REMOVE RESIDUE, TAKING CARE NOT TO ACTUATE THE HAND PIECE. IF DESIRED, THE INSTRUMENT MAY BE UNPLUGGED. THE INSTRUMENTS ALLOW FOR THE COAGULATION OF VESSELS UP TO AND INCLUDING 7 MM IN DIAMETER, USING THE ADVANCED HEMOSTASIS HAND CONTROL BUTTON. DO NOT ATTEMPT TO SEAL VESSELS IN EXCESS OF 7 MM IN DIAMETER. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE. SHOULD THE DEVICE BECOME AVAILABLE FOR RETURN, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HARMONIC SCALPEL (HARH45) FAILED, IT WAS NOT SEALING PROPERLY. THIS WAS NOTED POST OPERATION. IT WAS STATED THE VESSEL WAS FULLY SEALED DURING THE BARIATRIC PROCEDURE, THE PATIENT WAS RELEASED, BUT CAME BACK AND THE VESSEL WAS BLEEDING AND THE PATIENT EXPIRED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388408 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND HARH45 07613327346244

    Patients

    Seq Age Sex Outcome Treatment
    1 Death