BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 14823666 · Received June 26, 2022

    Report

    Report Number
    2955842-2022-12456
    Event Type
    Injury
    Date Received
    June 26, 2022
    Report Date
    April 23, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CAN BE ATTRIBUTED TO SURGICAL TECHNIQUE AND UNEXPECTED PATIENT ANATOMY. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. THE SYSTEM INFORMATION AND EVENT/PROCEDURE DATE ARE UNKNOWN. NO IMAGES OR VIDEOS WERE SHARED FOR THE EVENT. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: WITHIN THE ANNALS OF SURGICAL TREATMENT AND RESEARCH ARTICLE TITLED, ¿INITIAL EXPERIENCES OF ROBOTIC SP CHOLECYSTECTOMY: A COMPARATIVE ANALYSIS WITH ROBOTIC SI SINGLE-SITE CHOLECYSTECTOMY,¿ IT IS NOTED THAT ONE A PATIENT HAD A SMALL BOWEL INJURY DURING PORT PLACEMENT DUE TO UNEXPECTED INTRA-ABDOMINAL ADHESIONS WHICH WAS REPAIRED INTRA-CORPOREALLY. ALTHOUGH THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, IT IS UNKNOWN AS TO WHAT EXTENT (IF ANY) THE DA VINCI SURGICAL SYSTEM MAY HAVE CONTRIBUTED TO THE COMPLICATION. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IS NOT AVAILABLE. FIELD IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN ANNALS OF SURGICAL TREATMENT AND RESEARCH ARTICLE TITLED, ¿INITIAL EXPERIENCES OF ROBOTIC SP CHOLECYSTECTOMY: A COMPARATIVE ANALYSIS WITH ROBOTIC SI SINGLE-SITE CHOLECYSTECTOMY¿ (CRUZ, C. J., HUYNH, F., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED: ¿ONE PATIENT HAD A SMALL BOWEL INJURY DURING PORT PLACEMENT DUE TO UNEXPECTED INTRA-ABDOMINAL ADHESIONS, WHICH WAS REPAIRED INTRA-CORPOREALLY.¿ INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171304 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-34 N/A 00886874114605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES