BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 20341394 · Received October 1, 2024

    Report

    Report Number
    2955842-2024-20111
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 11, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874111083
    PMA / PMN Number
    K112584
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) [FAE/CDE/OTHER]. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THESE PICTURES ARE ALL PRETTY ZOOMED OUT SO IT¿S HARD TO TELL. FROM THE LOOKS OF IT, IT APPEARS THAT THE TEFLON PAD IS PARTLY ATTACHED TO THE CLAMP ARM BUT CAN¿T SAY FOR SURE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM HARMONIC ACE INSERT ACCESSORY FOR FAILURE ANALYSIS INVESTIGATION. THE ACCESSORY WAS ANALYZED AND WAS FOUND TO HAVE THE TEFLON PAD MISSING FROM THE CLAMP ARM. THE MISSING TEFLON PAD WAS NOT RETURNED WITH THE ACCESSORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE DA VINCI INSERT HARMONIC ACE INSTRUMENT, AFTER THE ULTRASONIC TOOL BIT IS PUT ON THE MACHINE, THE GASKET FELL OFF FOR A WHILE. THERE IS NO REPORT OF FRAGMENT FELL INTO PATIENT. A BACKUP SAME DV INSTRUMENT WAS USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT INFORMATION IS NOT AVAILABLE. NURSES AND DOCTORS IN THIS HOSPITAL ARE VERY EXPERIENCED ROBOT CUSTOMERS. EVERY OPERATION IS CARRIED OUT ACCORDING TO THE STANDARD WE TEACH. THE SURGEONS DON'T KNOW WHY THE GASKET WILL FALL OFF, AND THE GASKET WILL FALL OFF WHEN GRASPING THE TISSUE LESS THAN HALF AN HOUR AFTER THE COMPUTER. FOLLOW-UP ROBOT SURGERY IS COMPLETED BY SIMILAR STANDBY INSTRUMENTS. OTHER RELATED MATERIALS ARE NOT DAMAGED, AND THERE IS NO COLLISION DURING THE CUSTOMER FEEDBACK OPERATION. RELEVANT PHOTOS AND VIDEOS CAN BE PROVIDED DURING THE OPERATION, AND THE COMPLAINT PROCESS HAS BEEN UPLOADED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948086 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 400272-03 L10230803 10886874111083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.