BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 16883294 · Received May 6, 2023

    Report

    Report Number
    2955842-2023-12637
    Event Type
    Malfunction
    Date Received
    May 6, 2023
    Date of Event
    November 15, 2021
    Report Date
    December 7, 2021
    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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. ANALYSIS SUMMARY SHOWS THE ENDOSCOPE WAS RECEIVED WITH MISSING SCREWS ON HOUSING. THE ENDOSCOPE SHOCK INDICATOR WASN¿T ACTIVATED. THE ENDOSCOPE WAS FOUND WITH DESICCANT CONTAINER DAMAGE OR LOOSE DESICCANT BALLS. THE ENDOSCOPE WAS RECEIVED WITH NOISE IN IC HOUSING DURING SHAKING. THERE WAS STRAIN RELIEF ON THE HOUSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE WAS DAMAGED AFTER A FALL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574849 NONE ENDOSCOPE GCJ INTUITIVE SURGICAL, INC 470056-08 N/A 00886874116562

    Patients

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