BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 15263490 · Received August 21, 2022

    Report

    Report Number
    2955842-2022-13588
    Event Type
    Injury
    Date Received
    August 21, 2022
    Date of Event
    July 19, 2022
    Report Date
    July 22, 2022
    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
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HARMONIC ACE INSTRUMENT HAS BEEN RETURNED FOR EVALUATION ON 08/17/2022; HOWEVER, FAILURE ANALYSIS INVESTIGATIONS HAS NOT BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED POST ENGINEERING EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE LOGS CONFIRMED THAT AN ESOPHAGECTOMY NON-TRANSTHORACIC ¿ TRANSCERVICAL SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2022 ON SYSTEM (B)(4). A REVIEW OF THE INSTRUMENT LOG FOR THE HARMONIC ACE INSTRUMENT (PN# 480275-8 LOT# L90211214-0020) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 ON SYSTEM (B)(4) FOR APPROXIMATELY 28 MIN. THE HARMONIC ACE INSTRUMENT IS A SINGLE USE DEVICE. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE HARMONIC ACE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY. AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, AND H2, AND H3. EVALUATION INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10. INTUITIVE SURGICAL INC. (ISI) HAS RECEIVED THE HARMONIC ACE INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED THE INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN BLADE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BLADE BROKEN AT ROUGHLY 0.174¿ FROM THE BASE. THE BROKEN PIECE WAS NOT RETURNED. CRACKED OR BROKEN BLADES ARE TRIGGERED BY ANY INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED. IN ADDITION SCRATCHES ON THE BLADE TIP MAY ALSO LEAD TO PREMATURE BLADE FAILURE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO MISHANDLING / MISUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NON TRANSTHORACIC ESOPHAGECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE CURVED SHEARS INSTRUMENT INSERT BROKE AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE 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
    301890 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L90211214 0020 10886874112738

    Patients

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