BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17039754 · Received June 1, 2023

    Report

    Report Number
    2955842-2023-15431
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    November 16, 2021
    Report Date
    November 16, 2021
    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

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED/REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE ENDOSCOPE WAS RECEIVED WITH SEVERE DAMAGE FOUND ON THE CABLE JACKET. THE ATTACHED ENDOSCOPE ADAPTER (AEA) WAS FOUND TO BE DAMAGED. DISCOLORATION OF IC HOUSING. DISTAL TIP CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE PLUS CORD WAS THINNING AND LIGHT IS VISIBLE, AND WHEN THE IMAGE WAS FLIPPED IT WAS SLOW TO DO SO. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029439 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-05 N/A 00886874116555

    Patients

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