BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIUM-LARGE CLIP APPLIER INSTRUMENT

    MDR report key: 3435840 · Received October 29, 2013

    Report

    Report Number
    2955842-2013-04692
    Event Type
    Injury
    Date Received
    October 29, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 30, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO CONFIRM ANY ISSUES WITH THE INSTRUMENT. THE INSTRUMENT MAIN TUBE WAS INSPECTED AND NO DAMAGE WAS FOUND. THE TIP WAS INSPECTED AND NO DAMAGE WAS FOUND ON THE CLEVIS OR TIPS. 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. BASED ON THE FAILURE INVESTIGATIONS FINDINGS, IT IS UNKNOWN WHAT PLASTIC PIECE REPORTEDLY FELL INTO THE PATIENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN RECEIVED ON (B)(4) 2013; HOWEVER, FAILURE ANALYSIS INVESTIGATIONS HAVE NOT BEEN COMPLETED AT THE TIME OF THIS REPORT. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED BECAUSE IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO RETRIEVE THE LITTLE PIECE OF PLASTIC THAT HAD FALLEN INTO THE PATIENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LITTLE PIECE OF THE PLASTIC FROM A MEDIUM-LARGE CLIP APPLIER INSTRUMENT HAD FALLEN INTO A PATIENT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE AND WAS RETRIEVED WITHOUT ANY HARM. THE METHOD OF RETRIEVAL WAS NOT REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. INTUITIVE SURGICAL INC. (ISI) ATTEMPTED TO CONTACT THE SITE TO OBTAIN MORE INFORMATION ABOUT THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554336 MEDIUM-LARGE CLIP APPLIER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 428053-12 S10130530 552

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES