BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS TIPCOVER ACCESSORY

    MDR report key: 4233397 · Received November 6, 2014

    Report

    Report Number
    2955842-2014-05625
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MCS TIP COVER ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE ACCESSORY IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THERE IS NO INDICATION THAT THE PATIENT SUSTAINED AN INJURY BECAUSE OF THE REPORTED CUSTOMER FAILURE MODE. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI SURGICAL PROCEDURE, A HOLE WAS OBSERVED ON THE MCS TIP COVER ACCESSORY. HOWEVER, AT THIS TIME, THE CAUSE OF THE HOLE ON THE MCS TIP COVER ACCESSORY IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED UF/IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: ACTIVE END WAS DEFECTIVE AND RAISED, WHICH CAUSED UNEVEN WEAR IN THE MONOPOLAR COVER. THIS CAUSED A HOLE THAT WAS NOT COVERED, WHICH WAS ABLE TO BRIEFLY TOUCH THE PATIENT'S BOWEL WHICH WAS BEING REMOVED - NO PATIENT HARM. ON (B)(6) 2014, ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS NOT RECORDED. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INVOLVED WITH THIS COMPLAINT WAS INSPECTED PRIOR TO THE SURGICAL PROCEDURE AND NO ISSUES WERE OBSERVED. THE INITIAL REPORTER DID NOT KNOW IF THE MCS INSTRUMENT WAS REMOVED AT ANY TIME DURING THE SURGICAL PROCEDURE AND BEFORE THE REPORTED EVENT OCCURRED. NO INSTRUMENT COLLISIONS WERE REPORTED. IN ADDITION, NO EVIDENCE OF ARCING OF ELECTRICAL ENERGY WAS OBSERVED DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED ON THE MCS INSTRUMENT. THE INITIAL REPORTER OF THIS COMPLAINT WAS UNABLE TO PROVIDE THE PATIENT'S CURRENT STATUS. SHE ALSO DID NOT KNOW WHAT TYPE OF ELECTROSURGICAL UNIT (ESU) WAS USED DURING THE SURGICAL PROCEDURE AND WHAT ESU SETTINGS WERE UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713430 MONOPOLAR CURVED SCISSORS TIPCOVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-14

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR