BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3900685 · Received June 27, 2014

    Report

    Report Number
    2955842-2014-03961
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE PRESACRAL BLEEDING OR THE INJURY AT THE DISTAL RECTUM DURING INTERSPHINCTERIC RESECTION (ISR). IN THE ARTICLE, THERE WERE NO PROCEDURE DATES, HOSPITAL NAME(S) OR SURGEON NAME(S) PROVIDED. THE JOURNAL ARTICLE DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED DURING THE REPORTED PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE PRIMARY REPORTER TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENTS; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE JOURNAL ARTICLE INDICATED THAT DURING A DA VINCI PROCEDURES, TWO PATIENTS EXPERIENCED INTRAOPERATIVE COMPLICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A JOURNAL ARTICLE TITLED, COMPLETELY ABDOMINAL INTERSPHINCTERIC RESECTION FOR LOWER RECTAL CANCER: FEASIBILITY AND COMPARISON OF ROBOT-ASSISTED AND OPEN SURGERY. THIS ARTICLE IS FROM ENDOSCOPY SURGICAL AND OTHER INTERVENTIONAL TECHNIQUES. ARTICLE WAS PUBLISHED ON 02 APRIL 2014. ACCORDING TO THE REPORTED ARTICLE, FIVE PATIENTS AND ONE PATIENT, RESPECTIVELY, IN THE OPEN AND THE RA GROUP WITH PRESACRAL BLEEDING, AND ONE INADVERTENT INJURY AT THE DISTAL RECTUM DURING ISR IN THE RA GROUP. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENTS. THE DA VINCI SYSTEM SERIAL NUMBER INVOLVED WITH EACH SURGICAL PROCEDURE WAS NOT INCLUDED IN THIS ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377710 DA VINCI SURGICAL SYSTEM ENDOSCOPIC ELECTROSURGICAL INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention