BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST STAPLER INSTRUMENT

    MDR report key: 3820843 · Received May 20, 2014

    Report

    Report Number
    2955842-2014-03092
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K113706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE INITIAL REPORTER'S COMPLAINT. THE INSTRUMENT GRIP CABLE WAS BROKEN AT THE DISTAL END OF THE INSTRUMENT. BROKEN SEGMENT CONTAINING THE CRIMP WAS MISSING. THE CABLE WAS STICKING OUT AT THE WRIST. THE GRIP WAS NOT WORKING DUE TO THIS ISSUE. NO OTHER DAMAGES WERE FOUND ON THE INSTRUMENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION OF A BROKEN GRIP CABLE, IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    AN INITIAL REPORT WAS SUBMITTED TO THE FDA ON (B)(4) 2014 WITH THE FAILURE ANALYSIS INFORMATION ON THE INSTRUMENT. AFTER FURTHER REVIEW OF THIS COMPLAINT, INTUITIVE SURGICAL, INC. (ISI) IS RETRACTING THE COMPLAINT BASED ON THE FOLLOWING REASON: THE SHEATH ON THE VESSEL SEALER WOULD COVER THE GRIP CABLES AND THE CONDUCTOR WIRES AND WOULD SERVE AS A PROTECTOR TO PREVENT ANY FRAGMENTS FROM FALLING OUT AND INTO A PATIENT. BASED ON THIS INFORMATION, THERE IS NO EVIDENCE THAT INSTRUMENT MALFUNCTIONED; THEREFORE THIS COMPLAINT IS NON-REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI LOW ANTERIOR RESECTION PROCEDURE, WHEN IT WAS TIME TO CLOSE THE TISSUE WITH THE STAPLER INSTRUMENT, THE SURGEON CLOSED ON THE TISSUE; HOWEVER, WHEN THE SURGEON TRIED TO OPEN THE STAPLER INSTRUMENT, THE STAPLER WOULD NOT OPEN. THE CABLE WAS BROKEN AT THE WRIST. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT. ISI HAS ATTEMPTED 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299776 ENDOWRIST STAPLER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410298-07 S12140114 402

    Patients

    Seq Age Sex Outcome Treatment
    1