BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 9742171 · Received February 21, 2020

    Report

    Report Number
    2955842-2020-10131
    Event Type
    Injury
    Date Received
    February 21, 2020
    Report Date
    February 5, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111505
    PMA / PMN Number
    K180033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. ISI HAS ATTEMPTED TO CONTACT THE SITE'S RISK MANAGEMENT DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS BASED ON THE PART # AND LOT # OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT NOTED IN THE FDA VOLUNTARY REPORT. THE SYSTEM LOGS REVEAL THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT IN QUESTION WAS LAST USED ON (B)(6) 2018. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE BASED ON THE AVAILABLE SYSTEM LOGS. HOWEVER, THE EVENT DATE OF THE REPORTED INCIDENT HAS NOT BEEN CONFIRMED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT ALLEGEDLY SUSTAINED A THERMAL BURN INJURY TO THE BLADDER DOME THAT REQUIRED REPAIR. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS USING A MONOPOLAR CURVED SCISSORS INSTRUMENT. IT IS UNKNOWN, HOWEVER, HOW THE THERMAL BURN INJURY OCCURRED.

    Description of Event or Problem · 1

    ON 02/05/2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA UF/IMPORTER REPORTER # (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: "WHILE UNDERGOING A ROBOTIC ASSISTED LAPAROSCOPIC TOTAL HYSTERECTOMY THE MONOPOLAR CURVED SCISSORS CAUSED A THERMAL INJURY TO THE PATIENTS BLADDER DOME. THIS WAS IDENTIFIED AND REPAIRED INTRA-OPERATIVELY WITH OVER SEW OF THE BLADDER DOME.¿ THE FOLLOWING INFORMATION IS UNKNOWN: THE SPECIFIC DATE THE EVENT OCCURRED IN (B)(6) 2018, WHAT SURGICAL TASK THE SURGEON WAS PERFORMING WHEN THE BURN INJURY OCCURRED, THE SEVERITY OF THE BURN INJURY, THE PROCEDURE OUTCOME, AND THE PATIENT'S CURRENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203930 ENDOWRIST;DAVINCI SI MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 420179-18 N12180517 664 00886874111505

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention