BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIA

    MDR report key: 23095719 · Received September 19, 2025

    Report

    Report Number
    1219930-2025-04175
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 26, 2025
    Report Date
    November 14, 2025
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GDW
    UDI-DI
    10884521543782
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED HANDLE NOTED NO ABNORMALITIES. FUNCTIONAL TESTING NOTED THAT THE HANDLE WAS INSERTED INTO A CHARGER RUNNING V16 SOFTWARE TO CHARGE. THE HANDLE WAS REMOVED FROM THE CHARGER, BUT IT DID NOT INITIALIZE. THE CURRENT INTERRUPT DEVICE (CID) FOR ONE OF THE BATTERY CELLS WAS OPEN. THIS WOULD CAUSE THE BATTERY TO BE PERMANENTLY DISABLED AND THE HANDLE WOULD NO LONGER BE ABLE TO INITIALIZE OR CHARGE. THE DATA SAVED TO THE HANDLE WAS EVALUATED, AND IT INDICATED THAT THE BATTERY HEALTH DIAGNOSTIC LIMITS FOR IMPLIED CURRENT WERE EXCEEDED. ONCE THE BATTERY HEALTH DIAGNOSTIC LIMITS ARE EXCEEDED WHILE CHARGING, THE BATTERY IS DISABLED, AND A CHARGING ERROR IS ANNUNCIATED THROUGH A RED FLASHING LIGHT ON THE CHARGER. THE DATA SAVED TO THE HANDLE INDICATED THAT THE CID OPENED AFTER THE BATTERY HEALTH DIAGNOSTIC LIMITS WERE EXCEEDED. IT WAS NOTED THAT THE HANDLE HAD 174 OF 300 PROCEDURES REMAINING. THE HANDLE WAS NOTED TO BE RUNNING V29.7 SOFTWARE. IT WAS REPORTED THAT THE SIGNIA POWER HANDLE SHUT OFF. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. IT WAS ALSO REPORTED THAT THE SIGNIA POWER HANDLE WAS NOT CHARGED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO COMPONENT FAILURE. THE BATTERY CELL CID IS AN INTEGRATED DESIGN FEATURE OF THE CELL THAT OPENS AND RENDERS THE BATTERY CELL NONFUNCTIONAL AND NON-CHARGEABLE WHEN BATTERY CELL LIFE HAS BEEN EXCEEDED. 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 PRODUCT: SIGSBCHGR, SIG POWER SIGSBCHGR ONE -BAY CHARGER (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, PRE-OPERATIVELY, THE CHARGER'S RED LAMP FLASHED DURING CHARGING. THE POWERED HANDLE DISPLAY TURNED BLACK AND NO LONGER DISPLAYED ANYTHING. THE HANDLE STOPPED FUNCTIONING. ANOTHER POWERED HANDLE WAS USED. THE CHARGER WORKED NORMALLY WITH OTHER HANDLES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723149 SIGNIA STAPLE, IMPLANTABLE GDW COVIDIEN SURGICAL SIGPHANDLE 10884521543782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE NOTE ON H11.