BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 16439834 · Received February 24, 2023

    Report

    Report Number
    2955842-2023-10892
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    April 12, 2022
    Report Date
    January 31, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    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 THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSERT WAS FOUND TO HAVE TEFLON PAD DAMAGE ON THE CLAMP ARM. PART OF THE TEFLON PAD WAS DISLODGED FROM THE CLAMP ARM, AND THE TIP OF THE TEFLON PAD WAS DAMAGED. NO MATERIAL APPEARED TO BE MISSING. THE ROOT CAUSE OF THIS FAILURE WAS ATTRIBUTED TO MISHANDLING OR MISUSE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE HARMONIC ACE (HA) INSTRUMENT WAS DAMAGED, AN INVESTIGATION WAS CONDUCTED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. ALTHOUGH THE COMPLAINT REGARDING THE REPORTED FAILURE WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE INSTRUMENT WAS DAMAGED, AND INFORMATION PROVIDED THROUGH FOLLOW-UP INDICATED THAT A FRAGMENT FELL INSIDE THE PATIENT DURING A DA VINCI-ASSISTED PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE (HA) INSTRUMENT WAS DAMAGED. ANOTHER INSTRUMENT WAS USED TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUE REPORTED. INTUITIVE SURGICAL, INC. (ISI) THEN FOLLOWED UP WITH THE INITIAL REPORTER TO VERIFY WITH THE SITE REPORTING THE COMPLAINT, AND AFTER PROVIDING THE CORRECT SITE INFORMATION, OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HA INSTRUMENT WAS DAMAGED AND THE INITIAL REPORTER INDICATED THAT A FRAGMENT FELL INSIDE OF THE PATIENT¿S ANATOMY, THE SPECIFIC AREA OF THE INSTRUMENT DAMAGE WAS NOT SPECIFIED. THE FALLEN FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858752 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L90220118 0269 10886874112738

    Patients

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