BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10444517 · Received August 24, 2020

    Report

    Report Number
    2955842-2020-10784
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    June 8, 2020
    Report Date
    July 30, 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 Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SMALL GRASPING RETRACTOR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. THE MISSING CRIMP MEASURES APPROXIMATELY 0.31" X 0.046"; HOWEVER, THE SIZE OF THE BROKEN CABLE SEGMENT COULD NOT BE CONFIRMED. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL IDLER PULLEY. THE FRAYED CABLE STRANDS ARE STUCK OUT AT THE WRIST. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE SUBMITTED IMAGE SHOWS A LOOSE PITCH CABLE ALONG WITH A FRAYED GRIP CABLE. THIS IS CONSISTENT WITH THE INVESTIGATION RESULTS FOUND DURING FAILURE ANALYSIS. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. A REVIEW OF THE INSTRUMENT LOG FOR THE SMALL GRASPING RETRACTOR INSTRUMENT LOT# N10171101 /SEQUENCE 0036 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON THE REPORTED EVENT DATE OF (B)(6) 2020 USING SYSTEM SK1805. THE ALLEGED EVENT OCCURRED ON THE 9TH USE OF THE INSTRUMENT. THE INSTRUMENT HAS 1 REMAINING USABLE LIFE WITH NO SUBSEQUENT USE RECORDED. THIS COMPLAINT IS A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING: THE SMALL GRAPTOR (GRASPING RETRACTOR) INSTRUMENTS ARE MULTIPLE-USE ENDOSCOPIC INSTRUMENTS WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM. THE INSTRUMENT IS DESIGNED TO GRAB, MANIPULATE, RETRACT, AND DISSECT TISSUE DURING A DA VINCI ASSISTED SURGICAL PROCEDURE. 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. THE PITCH CABLE IS FOUND TO BE BROKEN AND/OR MISSING AT THE DISTAL END OF THE INSTRUMENT DURING FAILURE ANALYSIS INVESTIGATION WITH NO EVIDENCE OF USER MISHANDLING OR MISUSE. WHILE THERE WAS NO HARM OR INJURY TO PATIENT, THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. DEVICE EXPIRATION DATE WAS LEFT BLANK AS THIS INSTRUMENT HAS 10 USAGES ALLOTTED TO IT, WHICH ARE TRACKED BY THE DA VINCI SURGICAL SYSTEM. THE INSTRUMENT HAS 1 REMAINING USABLE LIFE, THEREFORE, HAD NOT EXPIRED. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE FIELDS IN INITIAL REPORTER ADDRESS IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, A LOOSE AND DAMAGED CABLE WAS OBSERVED ON THE SMALL GRASPING RETRACTOR INSTRUMENT. A BACKUP INSTRUMENT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: INSPECTION WAS CONDUCTED PRIOR TO USE, NO KNOWN COLLISION WITH ANOTHER INSTRUMENT OR A HARD OBJECT WAS OBSERVED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907529 ENDOWRIST SMALL GRASPING RETRACTOR NAY INTUITIVE SURGICAL, INC 470318-08 N10171101 0036 00886874112441

    Patients

    Seq Age Sex Outcome Treatment
    1