BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 19356364 · Received May 20, 2024

    Report

    Report Number
    1717344-2024-01181
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 23, 2024
    Report Date
    July 25, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    BWA
    UDI-DI
    10884524000381
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION OF THE FOOTSWITCH FOUND NO PHYSICAL DAMAGES. FUNCTIONALLY, AFTER CONNECTING THE FOOTSWITCH THE DEVICE IMMEDIATELY ACTIVATED BIPOLAR WITHOUT BEING PRESSED. PRESSING THE FOOTSWITCH RESULTED IN NO CHANGE, THE DEVICE CONTINUED TO ACTIVATE. THE FOOTSWITCH WAS OPENED AND INSPECTED. THE METAL SWITCH INSIDE THE ASSEMBLY WAS OBSERVED TO BE STUCK IN THE "ON" POSITION. GENTLY PRESSING ON THE SWITCH RELEASED THE LEVER AND THE DEVICE THEN FUNCTIONED PROPERLY, ONLY ACTIVATING WHEN PRESSED. FURTHER INSPECTION FOUND EXCESS EPOXY ON THE SWITCH ASSEMBLY, RESULTING IN THE STUCK LEVER. IT WAS REPORTED THAT THE OUTPUT SOUND WAS GENERATED BY ITSELF EVEN WITHOUT STEPPING ON IT. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO QUALITY CONTROL DEFICIENCY. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: VLFT10GEN - VLFT10GEN FT SERIES ENERGY PLATFORMX1, SERIAL# UNKNOWN MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE DEVICE WAS CONNECTED TO THE UNIT FOR THE INSPECTION IMMEDIATELY AFTER DELIVERY, THE OUTPUT SOUND WAS GENERATED BY ITSELF EVEN WITHOUT STEPPING ON IT. THE UNIT OPERATED NORMALLY WHEN ANOTHER DEVICE WAS CONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616619 VALLEYLAB UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES BWA COVIDIEN MFG DC BOULDER E6009 408190 10884524000381

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown