BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17130089 · Received June 14, 2023

    Report

    Report Number
    2955842-2023-16322
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 19, 2023
    Report Date
    May 19, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 30 DEGREE ENDOSCOPE WAS ANALYZED AND FOUND TO CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE COMPLAINT REGARDING HEAVY BASE WAS CONFIRMED BY FAILURE ANALYSIS. THE ATTACHED ENDOSCOPE ADAPTER (AEA) WAS FOUND TO BE DAMAGED OR HAD A FRICTION ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE MOVEMENT WAS HEAVY FROM THE BASE. THE CUSTOMER NOTED NO IMPROVEMENT AFTER CLEANING THE ENDOSCOPE. IT WAS ALSO MENTIONED THAT THE ENDOSCOPE ROTATED 180 DEGREES AFTER INSTALLING THE ENDOSCOPE INTO THE UNIVERSAL SURGICAL MANIPULATOR (USM). INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ACCORDING TO THE CUSTOMER, THE 30-DEGREE ENDOSCOPE DID NOT MOVE IN A REVERSED CONTROL OR OPPOSITE DIRECTION. THE DISPLAYED IMAGE WAS NOT INVERTED. THE PROCEDURE WAS COMPLETED USING THE SAME ENDOSCOPE WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972553 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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