BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17177322 · Received June 21, 2023

    Report

    Report Number
    2955842-2023-16497
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 20, 2023
    Report Date
    May 22, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112212
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE A DISLODGED COMPONENT. THE ENDOSCOPE WAS MISSING A RETAINING RING AND SCREWS. THE ENDOSCOPE WAS ALSO FOUND WITH CORROSION TO THE ELECTRICAL CONTACTS AND CIRCUIT BOARD. THE COMPLAINT REGARDING PHYSICAL DAMAGE WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER THAT UNSPECIFIED PARTS HAD FALLEN OFF THE ENDOSCOPE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THE ENDOSCOPE FOR EVALUATION, BUT THE DEVICE HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED FOR ANALYSIS AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. IMAGES OF THE ENDOSCOPE DAMAGE ARE REPORTEDLY AVAILABLE, BUT THEY HAVE NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, UNSPECIFIED PARTS HAD FALLEN OFF THE ENDOSCOPE. THE CUSTOMER REPLACED THE ENDOSCOPE WITH A BACK-UP ENDOSCOPE AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. IT WAS NOTED THAT NO FRAGMENTS FROM THE ENDOSCOPE FELL INSIDE THE PATIENT'S ANATOMY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80365 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-64 N/A 00886874112212

    Patients

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