BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17073347 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15964
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 12, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE ENDOSCOPE WOULD FLIP UP TO DOWN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND REPORTED FAILURE WAS CONFIRMED. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF ATTACHED ENDOSCOPE ADAPTER (AEA) DAMAGED/FRICTION ISSUE, CABLE INTEGRITY (VISUAL DAMAGE) ZONE A, DISCOLORATION OF HOUSING, AND ENDOSCOPE BEARING FRICTION ISSUE. THE COMPLAINT REGARDING ENDOSCOPE MOTION ISSUE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE ENDOSCOPE WOULD FLIP UP TO DOWN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATION REPLICATED AND CONFIRMED THE REPORTED COMPLAINT, WHICH 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 SURGICAL PROCEDURE, THE ENDOSCOPE FLIPPED UP TO DOWN AND WOULD NOT STAY IN PLACE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED DURING A ROBOTIC UMBILICAL HERNIA REPAIR SURGICAL PROCEDURE. A 30-DEGREE ENDOSCOPE WAS INSTALLED AT THE TIME OF THE EVENT. THE 30-DEGREE ENDOSCOPE WAS FLIPPING AND WOULD NOT STAY IN EITHER UP OR DOWN POSITION. THERE WAS DAMAGE OBSERVED ON THE ENDOSCOPE¿S ADAPTER/BASE. THE VISION ISSUE DID NOT RESULT IN PATIENT INJURY. A BACKUP ENDOSCOPE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696385 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