BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 13418001 · Received February 1, 2022

    Report

    Report Number
    2955842-2022-10157
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    November 29, 2021
    Report Date
    January 7, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111659
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TENACULUM FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT "CUSTOMER FOUND BROKEN CABLES". FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN PITCH CABLE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE ROOT CAUSE FOR THE BROKEN PITCH CABLE WAS FOUND TO BE A COMPONENT FAILURE AND RELATED TO DEVICE DESIGN. A REVIEW OF THE INSTRUMENT LOG FOR THE TENACULUM FORCEPS (PART # 420207-10/LOT# K10200907 102) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021, ON SYSTEM SH1860. THE INSTRUMENT HAD 4 USES REMAINING AFTER LAST USE. THE INSTRUMENT WAS NOT USED ON THE EVENT DATE OF (B)(6) 2021. IN ADDITION, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THIS INSTRUMENT IS DESIGNED WITH TWO PITCH CABLES, EACH WITH A CRIMP AT THE DISTAL END. IF A PITCH CABLE BREAKS AT THE DISTAL END, A CABLE SEGMENT AND/OR THE CRIMP COULD FALL INTO THE PATIENT. ALTHOUGH NO PATIENT HARM OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO HAVE BROKEN CABLES. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN THE INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501338 ENDOWRIST;DAVINCI SI TENACULUM FORCEPS NAY INTUITIVE SURGICAL, INC 420207-10 N10200907 102 00886874111659

    Patients

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