BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 13483873 · Received February 8, 2022

    Report

    Report Number
    2955842-2022-10200
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    October 30, 2021
    Report Date
    January 16, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED BATTERY FAILURE CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SITE HISTORY COMPLAINT REVIEW WAS UNABLE TO BE CONDUCTED AT THIS TIME DUE TO LACK OF INSTRUMENT DETAIL AND LACK OF SPECIFIC EVENT/PROCEDURE DETAIL. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿NEUROVASCULAR STRUCTURE-ADJACENT FROZEN-SECTION EXAMINATION ROBOTIC-ASSISTED RADICAL PROSTATECTOMY: OUTCOMES FROM 500 CONSECUTIVE CASES IN THE UK,¿ IT IS NOTED THAT A TEMPORARY CONVERSION TO LAPAROSCOPY OCCURRED WHEN THE ROBOT MALFUNCTIONED DUE TO BATTERY FAILURE. THE CAUSE OF THE REPORTED BATTERY FAILURE IS UNKNOWN. REFER TO MEDWATCH REPORT WITH PATIENT IDENTIFIER # (B)(6) FOR ADDITIONAL INFORMATION REGARDING THE MORTALITY 30 DAYS AFTER SURGERY FROM A CAECAL RUPTURE. REFER TO MEDWATCH REPORT WITH PATIENT IDENTIFIER # (B)(6) FOR ADDITIONAL INFORMATION REGARDING THE ANURIC PATIENT REQUIRING ADDITIONAL MEDICAL INTERVENTION 30 DAYS POST-PROCEDURE. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EVEN DATE IS UNKNOWN. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INTUITIVE SURGICAL, INC (ISI) BECAME AWARE OF A ¿JOURNAL OF ROBOTIC SURGERY¿ ARTICLE TITLED, ¿NEUROVASCULAR STRUCTURE-ADJACENT FROZEN-SECTION EXAMINATION ROBOTIC-ASSISTED RADICAL PROSTATECTOMY: OUTCOMES FROM 500 CONSECUTIVE CASES IN THE (B)(6)¿ (NOËL, J., SPENCER, N. H., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: "TWO INTRAOPERATIVE COMPLICATIONS INCLUDED A TEMPORARY CONVERSION TO LAPAROSCOPY WHEN ROBOT MALFUNCTIONED DUE TO BATTERY FAILURE AND AN ANURIC PATIENT POST-RALP NEEDING BILATERAL NEPHROSTOMIES ON DAY 2. THERE WAS ONE MORTALITY AFTER 30 DAYS FROM SURGERY FROM A CAECAL RUPTURE." ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301053 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-11 N/A 00886874110690

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES.