BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTER

    MDR report key: 23368557 · Received October 23, 2025

    Report

    Report Number
    3033118964-2025-00001
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 14, 2025
    Report Date
    October 23, 2025
    Manufacturer
    DISTALMOTION SA
    Product Code
    SDD
    UDI-DI
    07640184840608
    PMA / PMN Number
    K251197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MONOPOLAR SCISSORS INSTRUMENT WAS RETURNED FOR ANALYSIS. INSPECTION CONFIRMED INSULATION DAMAGE IN THE TIP SLEEVE REGION; TWO HOLES WERE OBSERVED. REVIEW OF PRODUCTION RECORDS REVEALED NO MANUFACTURING ANOMALIES, AND NO EVIDENCE OF MATERIAL OR ASSEMBLY DEFECT WAS FOUND. THE HOLES WERE LIKELY CAUSED BY CONTACT WITH THE DISTAL FORK UNDER HIGH ANGULATION OR PROXIMITY TO OTHER DEVICES DURING USE. THIS DAMAGE CAN COMPROMISE INSULATION, LEADING TO SHORT CIRCUIT AND THERMAL DAMAGE WHEN ENERGIZED. THE DAMAGE IS CONSISTENT WITH MECHANICAL STRESS DURING USE, HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING THE DISSECTION OF THE PERITONEUM FOR AN EPIGASTRIC VENTRAL HERNIA USING A TAPP PROCEDURE, IT WAS REPORTED THAT AFTER 36 MINUTES OF ROBOTIC CONSOLE TIME, MONOPOLAR ENERGY WAS DELIVERED VIA THE TIP SLEEVE OF THE MONOPOLAR SCISSORS TO TISSUE ON ALREADY CHARRED AND COAGULATED ANATOMICAL PLANES. NO CRITICAL STRUCTURES SUCH AS NERVES OR VESSELS PRESENT OR IMPACTED. VISUALIZATION OF THE INSTRUMENT BY THE ENDOSCOPE UNDER 10X MODIFICATION DID NOT OBSERVE ANY DEFECT. ALTHOUGH AN INSTRUMENT EXCHANGE WAS RECOMMENDED, THE SURGEON OPTED TO CONTINUE WITH THE EXISTING DEVICE DUE TO ITS ADEQUATE ENERGY DELIVERY AT THE TIP AND OVERALL SATISFACTORY PERFORMANCE AND DID NOT WISH TO PROLONG THE PROCEDURE TO EXCHANGE THE INSTRUMENT. ENERGY APPLICATION DURING THE PROCEDURE WAS CONSISTENTLY DEEMED SAFE, AS THE SURGEON MAINTAINED CLEAR VISUAL CONTROL OVER THE LOCATION, TIMING, AND INTENSITY OF ENERGY DELIVERY TO THE INTENDED TISSUE. THE MALFUNCTION CARRIED ONLY A MINOR RISK OF INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT INCIDENT, NO HARM OCCURRED THAT REQUIRED MEDICAL OR SURGICAL INTERVENTION.

    Description of Event or Problem · 0

    DURING THE DISSECTION OF THE PERITONEUM FOR AN EPIGASTRIC VENTRAL HERNIA USING A TAPP PROCEDURE, IT WAS REPORTED THAT AFTER 36 MINUTES OF ROBOTIC CONSOLE TIME, MONOPOLAR ENERGY WAS DELIVERED VIA THE TIP SLEEVE OF THE MONOPOLAR SCISSORS TO TISSUE ON ALREADY CHARRED AND COAGULATED ANATOMICAL PLANES. NO CRITICAL STRUCTURES SUCH AS NERVES OR VESSELS PRESENT OR IMPACTED. VISUALIZATION OF THE INSTRUMENT BY THE ENDOSCOPE UNDER 10X MODIFICATION DID NOT OBSERVE ANY DEFECT. ALTHOUGH AN INSTRUMENT EXCHANGE WAS RECOMMENDED, THE SURGEON OPTED TO CONTINUE WITH THE EXISTING DEVICE DUE TO ITS ADEQUATE ENERGY DELIVERY AT THE TIP AND OVERALL SATISFACTORY PERFORMANCE AND DID NOT WISH TO PROLONG THE PROCEDURE TO EXCHANGE THE INSTRUMENT. ENERGY APPLICATION DURING THE PROCEDURE WAS CONSISTENTLY DEEMED SAFE, AS THE SURGEON MAINTAINED CLEAR VISUAL CONTROL OVER THE LOCATION, TIMING, AND INTENSITY OF ENERGY DELIVERY TO THE INTENDED TISSUE. THE MALFUNCTION CARRIED ONLY A MINOR RISK OF INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT INCIDENT, NO HARM OCCURRED THAT REQUIRED MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2778471 DEXTER DEXTER MONOPOLAR SCISSORS SDD DISTALMOTION SA 518 518A202503X11547 07640184840608

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female