BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL CLIP APPLIER INSTRUMENT

    MDR report key: 3325632 · Received September 4, 2013

    Report

    Report Number
    2955842-2013-03369
    Event Type
    Injury
    Date Received
    September 4, 2013
    Date of Event
    July 25, 2013
    Report Date
    August 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. INTUITIVE SURGICAL INC. (ISI) HAS MADE SEVERAL ATTEMPTS 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 ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI SURGICAL PROCEDURE, THE SURGEON INDICATED THAT ONE OF THE TWO STRUT ARMS OF THE CLIP APPLIER INSTRUMENT WAS FOUND TO BE FRACTURED AND THE SURGEON WAS UNABLE TO LOCATE THE METAL TIP FRAGMENT. HOWEVER, AT THIS TIME, IT IS UNCLEAR IF THE BROKEN FRAGMENT ALLEGEDLY FELL INTO THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED UF/IMPORTER REPORT 0039-0223-201-0003 WITH THE FOLLOWING EVENT DESCRIPTION: A (B)(6) FEMALE UNDERWENT FIBEROPTIC BRONCHOSCOPY WITH LAVAGE, CERVICAL MEDIASTINOSCOPY, RIGHT THORACOSCOPY, ROBOTIC MIDDLE LOBECTOMY AND MEDIASTINAL LYMPH NODE DISSECTION ON (B)(6) 2013. INTRAOPERATIVELY, THE SURGEON IDENTIFIED THAT ONE OF THE TWO STRUT ARMS OF THE CLIP APPLIER WAS FRACTURED, A PIECE OF METAL APPROXIMATELY ONE TO TWO CENTIMETERS IN SIZE. THE SURGEON'S ATTEMPTS TO LOCATE THIS METAL TIP FRAGMENT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439920 SMALL CLIP APPLIER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420003-06 S10120522

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES