BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROB12C4

    MDR report key: 24492734 · Received March 3, 2026

    Report

    Report Number
    3003408255-2026-00001
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    February 2, 2026
    Report Date
    May 18, 2026
    Manufacturer
    SOUND TECHNOLOGY INC.
    Product Code
    ITX
    UDI-DI
    05704916001599
    PMA / PMN Number
    K223830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS COPENHAGEN - MILEPARKEN 34 DK 2730 DENMARK HERLEV. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE ROBOTIC ULTRASOUND PROBE CONNECTION WAS NOT WORKING AND DISPLAYED AN ERROR MESSAGE. MULTIPLE ATTEMPTS WERE MADE TO CONNECT THE PROBE, RESET AND SHUT DOWN THE SYSTEM; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. AS A RESULT, THE SURGICAL APPROACH WAS MODIFIED TO UTILIZE A LAPAROSCOPIC ULTRASOUND PROBE, AND A TOTAL NEPHRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303529 ROB12C4 TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX SOUND TECHNOLOGY INC. 9096 05704916001599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other