BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIA

    MDR report key: 23489499 · Received November 6, 2025

    Report

    Report Number
    1219930-2025-05133
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    July 11, 2025
    Report Date
    January 16, 2026
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GDW
    UDI-DI
    10884521543782
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE SIGNIA POWERED HANDLE FOR A NON-REPORTABLE CONDITION. THE DATA SAVED TO THE HANDLE WAS EVALUATED, AND IT INDICATED THAT THE BATTERY HEALTH DIAGNOSTIC LIMITS FOR CELL TEMPERATURE WAS 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 THE HANDLE VENTED AFTER THE BATTERY HEALTH DIAGNOSTIC LIMITS WERE EXCEEDED. IT WAS REPORTED THAT THE SIGNIA POWER HANDLE DID NOT CHARGED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE EVALUATION DETECTED AN UNREPORTED CONDITION OF A VENTED BATTERY. THIS CONDITION HAS A POTENTIAL FOR PATIENT HARM. VISUAL INSPECTION OF THE OPENED HANDLE FOUND ONE BATTERY WAS VENTED, WET WITH ELECTROLYTIC FLUID. ROOT CAUSE OF THE OBSERVED VENTED BATTERY WAS DETERMINED TO BE DUE TO A COMPONENT DEGRADATION. THE CELL VENTING IS AN INTEGRATED DESIGN FEATURE OF THE CELL THAT PRODUCES A DISCHARGE OF THE ELECTROLYTE FLUID AND RENDERS THE BATTERY CELL NONFUNCTIONAL AND NON-CHARGEABLE WHEN BATTERY CELL LIFE HAS BEEN EXCEEDED. DEVICE BATTERY MANAGEMENT ENHANCEMENTS HAVE BEEN IMPLEMENTED TO EXTEND BATTERY LIFE AND ENHANCE BATTERY HEALTH MONITORING. 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

    IT WAS REPORTED THAT THE POWERED HANDLE WAS NOT TAKING ANY CHARGE DURING PRE-OPERATIVE PREPARATION. THE CHARGER WAS TESTED WITH A DEMONSTRATION HANDLE AND WAS FOUND TO BE FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE ONE BATTERY CELL WAS FOUND TO BE VENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084305 SIGNIA STAPLE, IMPLANTABLE GDW COVIDIEN SURGICAL SIGPHANDLE 10884521543782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown