BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 18453621 · Received January 5, 2024

    Report

    Report Number
    2955842-2023-21935
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    December 13, 2023
    Report Date
    December 13, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K181395
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SEAL AND COMPLETED FAILURE ANALYSIS INVESTIGATIONS. FAILURE ANALYSIS REPLICATED/CONFIRMED THE CUSTOMER-REPORTED COMPLAINT. THE SEAL WAS FOUND TO HAVE A BROKEN LUER FITTING.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE WAS NO DAMAGE TO THE ACCESSORY OR ANYTHING OUT OF THE ORDINARY UPON INITIAL INSPECTION. THE WAS NO DAMAGE TO THE ACCESSORY OR ANYTHING OUT OF THE ORDINARY UPON INITIAL INSPECTION. THE SURGEON DID NOT DISCUSS HIS THOUGHTS ON HOW THE INSUFFLATION PORT BROKE. THE INSTRUMENT WAS IN USE FOR ROUGHLY 10 TO 20 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT THINK THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. THE CUSTOMER DISCOVERED THAT THE INSUFFLATION PORT WAS BROKEN AFTER DOCKING THE ROBOT. UPON FINAL REMOVAL OF THE INSTRUMENT, THE SURGICAL STAFF FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE FRAGMENT WAS STILL ATTACHED TO THE INSUFFLATION TUBING. YES, ALL OF THE FRAGMENTS WERE RETRIEVED AND CONFIRMED. NO ADDITIONAL SURGERIES WERE PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY AFTER REPLACING THE DAMAGED CAP. NO, THERE WAS NO INJURY TO THE PATIENT. NO MEDIA IS AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA TRANSABDOMINAL PRE-PERITONEAL (TAPP) SURGICAL PROCEDURE, THE UNIVERSAL SEAL INSUFFLATION PORT BROKE OFF DURING CASE. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762315 DA VINCI SEAL GCJ INTUITIVE SURGICAL, INC 470500-13 K13230719

    Patients

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