BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 16110413 · Received January 6, 2023

    Report

    Report Number
    2955842-2022-16291
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 6, 2022
    Report Date
    December 6, 2022
    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
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS (FA). FA CONFIRMED/REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE ENDOSCOPE HAD DISTAL TIP CONTAMINATION. THE ENDOSCOPE WAS CLEAN AND IT WAS JUST DIRTY. THE ENDOSCOPE HAD LEAKS AT PROXIMAL FIBERS (IC)/ CONNECTOR AND ENDOSCOPE ADAPTOR (AEA) DAMAGED OR FRICTION ISSUE. THE ENDOSCOPE HAD SCOPE BEARING FRICTION ISSUE AND BUTTON MECHANICAL DAMAGE. THE ENDOSCOPE HAD DAMAGE AT IC HOUSING AND DEFORMED CABLE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE ENDOSCOPE ROTATING ON ITS OWN, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED COMPLAINT. SYSTEM TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE ENDOSCOPE IN ORDER TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. A FOLLOW-UP MDR WILL BE SUBMITTED POST FAILURE ANALYSIS EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED. THE PROBABLE ROOT CAUSE OF THE SCOPE ROTATING ON ITS OWN CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE ENDOSCOPE WOULD ROTATE ON ITS OWN TWISTING THE SURGEON'S HAND ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. POOR CAMERA CONTROL COULD RESULT IN UNINTUITIVE MOTION AND SUBSEQUENT TISSUE DAMAGE. AT THIS TIME, THE ROOT CAUSE OF THE FAILURE IS UNKNOWN. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN COLPOSUSPENSION HYSTERECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE WOULD ROTATE ON ITS OWN TWISTING THE SURGEON'S HAND ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE INTUITIVE SURGICAL, INC. (ISI TECHNICAL SUPPORT ENGINEER (TSE) DID NOT FIND ANY ERRORS AT TIME OF INCIDENT BUT FOUND EARLIER DRAPE ERRORS ON USM 2. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535438 NONE ENDOSCOPE GCJ INTUITIVE SURGICAL, INC 470056-05 N/A 00886874116562

    Patients

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