BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUGO¿ RAS SYSTEM

    MDR report key: 23904520 · Received December 29, 2025

    Report

    Report Number
    1219930-2025-06080
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 9, 2025
    Report Date
    March 17, 2026
    Manufacturer
    SURGICAL
    Product Code
    SCV
    UDI-DI
    10884521826632
    PMA / PMN Number
    K250725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    H3) EVALUATION SUMMARY: MEDTRONIC LED AN EVALUATION OF AN IMAGE PROVIDED FOR THE REPORTED ARM CART ASSEMBLY. ONE IMAGE WAS RECEIVED. THE IMAGE SHOWED A WIDENED AND LOOSE DRAPE CLIP OF AN ARM CART ASSEMBLY INSIDE OF AN OPERATING ROM. THE DRAPE WAS HANGING OUT OF THE ARM CART. EVALUATION OF THE ARM CART ASSEMBLY CONFIRMED THE REPORTED CONDITION, HOWEVER, THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION; THEREFORE, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A ROOT CAUSE. HOWEVER, THE MOST LIKELY CAUSE COULD BE TRACED TO A FAULTY DRAPE CLIP. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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 DURING A ROBOTIC LAPAROSCOPIC COLPOPEXY PROCEDURE, THE CAMERA ARM MOVEMENT WAS REPEATEDLY OBSTRUCTED BECAUSE THE ARM DRAPE BECAME STUCK IN THE DRAPE CLIP EACH TIME THE SURGEON ATTEMPTED TO INSERT OR MOVE THE CAMERA INSIDE THE PATIENT. THIS OBSTRUCTION PREVENTED SMOOTH CAMERA ARM MOVEMENT AND REQUIRED THE SURGICAL TEAM TO STOP THE PROCEDURE MULTIPLE TIMES TO MANUALLY FREE THE DRAPE FROM THE CLIP. THE DRAPE CLIP HAD WIDENED AND COULD NO LONGER SECURE THE DRAPE PROPERLY, CAUSING THE OBSTRUCTION TO RECUR WITH EVERY CAMERA INSERTION. THE PROCEDURE WAS CONTINUED BY MANUALLY CLEARING THE OBSTRUCTION EACH TIME IT OCCURRED. THE ISSUE WAS NOT RESOLVED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC COLPOPEXY PROCEDURE, THE CAMERA ARM MOVEMENT WAS REPEATEDLY OBSTRUCTED BECAUSE THE ARM DRAPE BECAME STUCK IN THE DRAPE CLIP EACH TIME THE SURGEON ATTEMPTED TO INSERT OR MOVE THE CAMERA INSIDE THE PATIENT. THIS OBSTRUCTION PREVENTED SMOOTH CAMERA ARM MOVEMENT AND REQUIRED THE SURGICAL TEAM TO STOP THE PROCEDURE MULTIPLE TIMES TO MANUALLY FREE THE DRAPE FROM THE CLIP. THE DRAPE CLIP HAD WIDENED AND COULD NO LONGER SECURE THE DRAPE PROPERLY, CAUSING THE OBSTRUCTION TO RECUR WITH EVERY CAMERA INSERTION. THE PROCEDURE WAS CONTINUED BY MANUALLY CLEARING THE OBSTRUCTION EACH TIME IT OCCURRED. THE ISSUE WAS NOT RESOLVED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511832 HUGO¿ RAS SYSTEM MODULAR ELECTROMECHANICAL SURGICAL SYSTEM SCV SURGICAL MRASC0002 10884521826632

    Patients

    Seq Age Sex Outcome Treatment
    1