BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTER

    MDR report key: 23666057 · Received November 27, 2025

    Report

    Report Number
    3033118964-2025-00003
    Event Type
    Malfunction
    Date Received
    November 27, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 27, 2025
    Manufacturer
    DISTALMOTION SA
    Product Code
    SDD
    UDI-DI
    07640184840622
    PMA / PMN Number
    K251197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE PROCEDURE, THE SURGEON IDENTIFIED A SMALL HOLE IN THE INSTRUMENT TIP INSULATION AND HE ELECTED TO CONTINUE THE SURGERY. A SINGLE, SUPERFICIAL, LINEAR CAUTERIZATION MARK WAS NOTED IN THE LIVER CAPSULE. THE MARK DID NOT PENETRATE THE CAPSULE, INVOLVED NO BLEEDING AND HAD CAUSED NO INJURY TO VASCULAR OR BILIARY STRUCTURES. NO CLINICAL TREATMENT OR FOLLOW-UP ACTION WAS REQUIRED, AND NO POST-OPERATIVE SYMPTOMS OR COMPLICATIONS WERE REPORTED. IT IS NOTED THAT, DURING SUCH PROCEDURES, SIMILAR SUPERFICIAL MARKS MAY OCCUR DURING STANDARD MONOPOLAR USE HOOK AND GENERALLY REQUIRE NO INTERVENTION IF NO EXTENSIVE AND IN THE ABSENCE OF BLEEDING OR HEMATOMA. THE MONOPOLAR HOOK INSTRUMENT WAS RETURNED FOR ANALYSIS. INSPECTION CONFIRMED INSULATION DAMAGE IN THE TIP SLEEVE REGION; ONE HOLE WAS OBSERVED. REVIEW OF PRODUCTION RECORDS REVEALED NO MANUFACTURING ANOMALIES, AND NO EVIDENCE OF MATERIAL OR ASSEMBLY DEFECT WAS FOUND. THE HOLE WAS 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 A CHOLECYSTECTOMY, A SMALL HOLE WAS OBSERVED IN THE INSULATION OF THE TIP SLEEVE OF THE MONOPOLAR HOOK INSTRUMENT. WHILE APPLYING ENERGY TO DISSECT THE GALLBLADDER, SPARKING WAS NOTED FROM THE HOLE, WHICH RESULTED IN ONE SMALL, LINEAR, CAUTERIZATION MARK TO THE LIVER CAPSULE. THE SAME INSTRUMENT WAS BEING USED FOR APPROXIMATELY 19 MINUTES WITHOUT ISSUES AND WAS EXTRACTED AND RE-INSERTED JUST BEFORE THE EVENT. NO FRICTION WAS REPORTED WHEN PASSING THE MONOPOLAR HOOK THROUGH THE TROCAR. SINCE THIS FINAL SURGICAL TASK REQUIRED LESS THAN 5 MINUTES, THE SURGEON DECIDED TO COMPLETE THE PROCEDURE WITHOUT REPLACING THE INSTRUMENT. THIS RESULTED IN A FEW SIMILAR, SMALL, CAUTERIZATION MARKS ON THE LIVER CAPSULE, CREATED UNDER FULL VISUAL CONTROL AND WITH DELIBERATE, CONTROLLED INSTRUMENT MOVEMENTS. PATIENT HARM WAS LIMITED TO MINOR LINEAR CAUTERIZATION OF THE LIVER CAPSULE, VISIBLE ON VIDEO. NO LACERATION OR HAEMORRHAGE WERE SEEN; NO HEPATIC STRUCTURES WERE INJURED. NO ADDITIONAL INTERVENTIONS WERE PERFORMED OR PLANNED. ENERGY SOURCE USED WAS ETHICON MEGADYNE, SET AT 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950275 DEXTER DEXTER MONOPOLAR HOOK SDD DISTALMOTION SA 520 520A202502X11546 07640184840622

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female