BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17067344 · Received June 5, 2023

    Report

    Report Number
    2955842-2023-15733
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    March 21, 2022
    Report Date
    March 25, 2022
    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
    MN
    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 INVESTIGATIONS DID REPLICATE/CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE ENDOSCOPE WAS RECEIVED WITH ATTACHED ENDOSCOPE ADAPTER (AEA) DAMAGE OR FRICTION ISSUE. THE ENDOSCOPE HAD DISCOLORATION OF THE IC HOUSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, THE 0 DEGREE ENDOSCOPE PLUS HAD AN IMAGE ORIENTATION ISSUE - THE IMAGE WAS MIRRORED. A BACKUP ENDOSCOPE WAS USED TO PROCEED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570185 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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