BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOPOLAR CURVED SCISSORS TIPCOVER ACCESSORY

    MDR report key: 5172943 · Received October 24, 2015

    Report

    Report Number
    2955842-2015-01321
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 25, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND MCS TIP COVER ACCESSORY INVOLVED WITH THE REPORTED EVENT AND COMPLETED INVESTIGATIONS. THE INSTRUMENT PASSED ENERGY DELIVERY AND ELECTRICAL CONTINUITY TESTING. NO PHYSICAL DAMAGE OR TROUBLE WAS FOUND ON THE INSTRUMENT. FAILURE ANALYSIS IDENTIFIED TWO HOLES ON THE MCS TIP COVER ACCESSORY WHICH IS INDICATIVE OF ARCING. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION OCCURRED CONSIDERING NO TROUBLE WAS FOUND WITH THE FAILURE ANALYSIS EVALUATION OF THE MCS INSTRUMENT. IN ADDITION, AS MENTIONED IN THE FOLLOW-UP 1 MDR SUBMITTED ON 11/25/2015, A PHARMACIST FROM THE SITE INDICATED THAT THE SURGEON THINKS HE MAY HAVE TOUCHED THE MCS WITH ANOTHER UNSPECIFIED INSTRUMENT DURING THE SURGICAL PROCEDURE WHICH CAUSED DAMAGE TO THE MCS TIP COVER ACCESSORY. BASED ON THE CURRENT INFORMATION OBTAINED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN UNSPECIFIED BURN INJURY TO THE UTERUS WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. BASED ON THE FAILURE ANALYSIS OF THE INSTRUMENT THERE WAS NO INDICATION THAT A MALFUNCTION OF THE MCS INSTRUMENT OR MCS TIP COVER ACCESSORY OCCURRED. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS STILL UNKNOWN.

    Additional Manufacturer Narrative · 1

    ON OCTOBER 27,2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE REGARDING THE REPORTED EVENT: A PHARMACIST FROM THE SITE INDICATED THAT THE SURGEON THINKS HE MAY HAVE TOUCHED THE MONOPOLAR CURVED SCISSORS (MCS) WITH ANOTHER UNSPECIFIED INSTRUMENT DURING THE SURGICAL PROCEDURE WHICH CAUSED DAMAGE TO THE MCS TIP COVER ACCESSORY. BASED ON THE ADDITIONAL INFORMATION OBTAINED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN UNSPECIFIED BURN INJURY TO THE UTERUS WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS STILL UNKNOWN.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY HAVE NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT AND/OR ACCESSORY ARE RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN UNSPECIFIED BURN INJURY TO THE UTERUS WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSES OF THE INTRA-OPERATIVE COMPLICATION AND HOLES ON THE MCS TIP COVER ACCESSORY ARE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED A BURN TO THE UTERUS WHILE THE SURGEON WAS USING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. TWO HOLES WERE FOUND ON THE MCS TIP COVER ACCESSORY INSTRUMENT. THE SEVERITY OF THE BURN IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT RECEIVED OR REQUIRED ANY MEDICAL INTERVENTION DUE TO THE BURN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703716 MONOPOLAR CURVED SCISSORS TIPCOVER ACCESSORY ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. 400180 M10150303

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention