BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 9988247 · Received April 22, 2020

    Report

    Report Number
    2955842-2020-10335
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    September 5, 2019
    Report Date
    March 27, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K150284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G4, G7, AND H2. CORRECTED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELD: G5. THE UPDATE CONTAINS THE PMA/510K NUMBER WHICH IS K150284.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED ISSUE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. A LOG REVIEW WAS PERFORMED FOR THE CADIERE FORCEPS INSTRUMENT REPORTED IN THIS COMPLAINT (PN: 470049-06/101181120 0020) AND THE FOLLOWING WAS FOUND: THE INSTRUMENT WAS LAST USED ON (B)(6) 2019 DURING A LOW ANTERIOR RESECTION PERFORMED ON SYSTEM SL0065. THE CADIERE FROCEPS INSTRUMENT WAS USED ON ITS 7TH LIFE/USAGE OF 10 FOR THIS PROCEDURE AND NOT USED FOR ANY FOLLOWING PROCEDURES. AS OF 4/20/2020, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THERE WAS NO PHOTO OR VIDEO AVAILABLE FOR ANALYSIS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THE BROKEN PITCH CABLE FOUND DURING FAILURE ANALYSIS COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A BROKEN CABLE. THERE WERE NO FRAGMENTS THAT FELL INSIDE OF THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT WITH NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449968 ENDOWRIST CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 470049-06 101181120 0020

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES