BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 MM FENESTRATED BIPOLARFORCEPS

    MDR report key: 7208476 · Received January 19, 2018

    Report

    Report Number
    2955842-2018-00048
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 25, 2017
    Report Date
    December 26, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) WILL NOT BE RECEIVING 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT FROM THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO BE MISSING. AT THIS TIME, THE LOCATION OF THE MISSING INSTRUMENT FRAGMENT IS UNKNOWN AND IT IS UNCLEAR IF THE MISSING INSTRUMENT FRAGMENT FELL AND WAS RETAINED INSIDE THE PATIENT.

    Additional Manufacturer Narrative · 1

    ON 01/28/ 2018 INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI SAFETY CONTROL SPECIALIST AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON REPORTED THAT THE INSTRUMENTS WERE INSPECTED BEFORE AND AFTER THE PROCEDURE. FURTHERMORE, THE SURGEON ALSO REPORTED THAT THE INSTRUMENT BREAKAGE OCCURRED OUTSIDE OF THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DEVICE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF PIECE OF THE INSULATOR OF THE BIPOLAR WAS CHIPPED. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN YAW PULLEY. INTUITIVE MOTION WAS NOT BEING EXPERIENCED UPON MANUAL INPUT OF THE DISK KNOBS BECAUSE OF THE PHYSICAL DAMAGE. THE YAW PULLEY WAS MISSING A PIECE APPROXIMATELY 0.19 X 0.08. CUSTOMER DID NOT RETURN MISSING PIECE. THE KNOWN COMMON CAUSE OF THIS FAILURE IS MISHANDLING/MISUSE. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE WAS CONDUCTED AND DID NOT FIND ANY NON-CONFORMANCES THAT WOULD AFFECT ANY MATERIAL OF THE FINAL PRODUCT AND/OR THE QUALITY OR PERFORMANCE OF THE INSTRUMENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED AND THE FAILURE ANALYSIS RESULTS, THIS MDR REPORT IS BEING RETRACTED. THE SURGEON REPORTED THAT THE INSTRUMENT BREAKAGE OCCURRED OUTSIDE THE PATIENT AND FAILURE ANALYSIS DETERMINED THAT THE DAMAGE TO THE INSTRUMENT WAS DUE TO MISHANDLING/MISUSE AND NOT DUE TO A MALFUNCTION OF THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A PIECE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS CHIPPED AND MISSING. IT IS UNKNOWN IF ANY INTRAOPERATIVE COLLISION OCCURRED OR IF A FRAGMENT(S) FROM THE INSTRUMENT WAS RETAINED INSIDE THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. INTUITIVE SURGICAL, INC. HAS MADE AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION CONCERNING 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
    51146 8 MM FENESTRATED BIPOLARFORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 470205-13

    Patients

    Seq Age Sex Outcome Treatment
    1