BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17319081 · Received July 13, 2023

    Report

    Report Number
    2955842-2023-17039
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 19, 2023
    Report Date
    June 19, 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
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ENDOSCOPE IMAGE ORIENTATION ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE ENDOSCOPE WAS TESTED BY THE DISTRIBUTOR REPRESENTATIVE AFTER PROCEDURE WITH TRAINING INSTRUMENTS AND IT WAS CONFIRMED THAT THE ENDOSCOPE WAS WORKING AS EXPECTED. NO SITE VISIT WAS CONDUCTED, AND NO PRODUCT RETURN IS REQUIRED. THE ENDOSCOPE WORKED AS EXPECTED AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. ALTHOUGH THE COMPLAINT REGARDING ORIENTATION ISSUE WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED FOR EVALUATION, OR ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RECTOPEXY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED ENDOSCOPE IMAGE ORIENTATION ISSUE. THE CUSTOMER STATED THAT WHEN THEY REMOVED THE ENDOSCOPE FOR CLEANING AND REINSTALLED IT, THE ENDOSCOPE ROTATED 180º BY ITSELF, MAKING PHYSICAL AND SOFTWARE HORIZON NOT COHERENT AND INSTRUMENTS MOVEMENT INVERTED. PRIOR TO CALLING THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE), THE CUSTOMER RESTARTED THE SYSTEM AND INSTALLED THE ENDOSCOPE ON A DIFFERENT UNIVERSAL SURGICAL MANIPULATOR TO RESOLVE THE ISSUE. THE TSE CONFIRMED WITH THE CUSTOMER THAT THE ENDOSCOPE COULD BE MANUALLY ROTATE WITH NO NOISE. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281514 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 001028-6132 00886874116555

    Patients

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