BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10495962 · Received September 4, 2020

    Report

    Report Number
    2955842-2020-10865
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    June 26, 2020
    Report Date
    August 10, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112441
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SMALL GRASPING RETRACTOR (SGR) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE SGR 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. A REVIEW OF THE INSTRUMENT LOG SHOWED THE SGR INSTRUMENT (PART #470318-10 / LOT #N10190826-0014) WAS LAST USED ON (B)(6) 2020 DURING THIS PROCEDURE WITH SYSTEM (B)(4). THE SGR INSTRUMENT HAS 10 ALLOTTED USES. THE ALLEGED EVENT OCCURRED ON ITS 3RD LIFE. THE SGR INSTRUMENT HAS NOT BEEN USED IN SUBSEQUENT PROCEDURES AFTER THE ALLEGED EVENT REPORTED ON THIS RECORD. IN ADDITION, A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THE SGR INSTRUMENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THIS SGR 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. 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 MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER NOTICED A FRAYED CABLE ON THE SMALL GRASPING RETRACTOR (SGR) INSTRUMENT AFTER IT WAS INSERTED INTO THE PATIENT'S BODY. PER THE REPORTER, NO FRAGMENT FELL INSIDE THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM, INJURY OR ADVERSE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SITE WAS PERFORMING A COLOSTOMY CLOSURE SURGICAL PROCEDURE. THE FRAYED CABLE WAS NOTED AFTER THE SGR INSTRUMENT WAS INSERTED INTO THE PATIENT¿S ABDOMINAL CAVITY. THE SITE REPLACED THE SGR INSTRUMENT AND CONTINUED WITH THE CASE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY PATIENT-RELATED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959307 ENDOWRIST SMALL GRASPING RETRACTOR NAY INTUITIVE SURGICAL, INC 470318-10 N10190826 0014 00886874112441

    Patients

    Seq Age Sex Outcome Treatment
    1