BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS

    MDR report key: 6551487 · Received May 8, 2017

    Report

    Report Number
    2955842-2017-00284
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Date of Event
    April 6, 2017
    Report Date
    April 12, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    UDI-DI
    00886874112359
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED FAILURE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN YAW PULLEY AT THE DISTAL END. THE YAW PULLEY WAS MISSING A 0.099 X 0.176. THIS ALLOWED THE GRIP TO WITHIN THE PULLEY AND HAVE A LARGER RANGE OF MOTION IN THE YAW. THE KNOWN COMMON CAUSE OF A BROKEN YAW PULLEY IS DUE TO MISHANDLING/ MISUSE. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE INVOLVED WITH THIS COMPLAINT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. BASED ON THE DEVICE EVALUATION RESULTS, THIS MDR REPORT IS BEING RETRACTED SINCE THE FAILURE MODE WAS FOUND TO BE DUE TO USER MISUSE/MISHANDLING AND NOT DUE TO A MALFUNCTION OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT FOR FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT A FRAGMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE FROM THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE. FURTHERMORE, THE PATIENT HAS NOT RETURNED DUE TO POST OPERATIVE COMPLICATIONS AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332399 FENESTRATED BIPOLAR FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 470205-14 S10161128 00886874112359

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR