BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 21299230 · Received February 3, 2025

    Report

    Report Number
    2955842-2025-01116
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 9, 2025
    Report Date
    January 9, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116562
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO IMPROPER CUSTOMER SETUP. BASED ON INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) NOTES, THE SYSTEM ISSUE WAS DUE TO AN ORIENTATION ISSUE OF THE 30-DEGREE ENDOSCOPE CAUSING THE CONTROLS TO BE FLIPPED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE 30-DEGREE ENDOSCOPE FOR EVALUATION. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) #1 AND USM #3 CONTROLS WERE FLIPPED. SITE RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). BEFORE THE PHONE CALL, SITE HAD REASSIGNED THE USM ARMS. TSE DID NOT FIND ANY RELATED ERRORS IN THE LOGS. TSE HAD SITE SWAP THE ENDOSCOPE VIEW ORIENTATION, WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE DID NOT RESULT IN PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158648 NONE ENDOSCOPE GCJ INTUITIVE SURGICAL, INC 470056-05 N/A 00886874116562

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES