BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3885066 · Received June 19, 2014

    Report

    Report Number
    2955842-2014-03791
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PK DISSECTING FORCEPS INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THAT THE INSTRUMENT'S PULLEY EXHIBITED CHARRING AT THE GRIP BASE. IT WAS CONCLUDED THAT THE CHARRING MAY BE DUE TO A BREACH IN THE INSULATION. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THE PITCH CABLE AT THE DISTAL IDLER WAS FRAYED. THERE WAS NO DAMAGE TO THE PULLEY AND THE CLEVIS. THE DISTAL EDGE OF THE DISTAL PULLEY EXHIBITED MECHANICAL INDENTATIONS/BURRS. THE SURFACE OF THE PULLEY HAD SCRATCHES. IT WAS CONCLUDED THAT THE DAMAGE TO THE PULLEY AND CLEVIS WAS LIKELY DUE TO MISHANDLING/MISUSE. ONE OF THE INSTRUMENT'S GRIP TIPS EXHIBITED A MECHANICAL INDENTATION AT THE BASE SIDE AREA. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS, HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE SITE'S DA VINCI COORDINATOR AND ISI'S FSE EVALUATION OF THE SITE'S SYSTEM, IT HAS BEEN DETERMINED THAT THE BURNS TO THE PATIENT'S PORT-SITE INCISIONS WERE NOT CAUSED BY A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. WHILE THERMAL DAMAGE TO THE BASE OF THE PK DISSECTING FORCEPS INSTRUMENT WAS FOUND DURING FAILURE ANALYSIS INVESTIGATION, IT HAS BEEN DETERMINED THAT INTERNAL ARCING IN BIPOLAR INSTRUMENTS RESULTS IN A POTENTIAL LOSS OF PRODUCT FUNCTION, BUT NO TRANSFER OF ENERGY TO THE PATIENT. THE SITE'S INTERNAL INVESTIGATION DETERMINED THAT THE THERMAL BURNS SUSTAINED BY THE PATIENT OCCURRED DUE TO A MALFUNCTION OF THEIR ESU. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING FAILURE ANALYSIS INVESTIGATION IT WAS DISCOVERED THAT THE PITCH CABLE AT THE DISTAL IDLER WAS FRAYED. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S PITCH CABLE, FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, DURING REMOVAL OF THE TROCAR FROM THE PATIENT. IT WAS DISCOVERED THAT 2 OF THE PATIENT'S PORT-SITE INCISIONS EXHIBITED BLACK MARKS THAT APPEARED TO BE CHARRED. REPORTEDLY, NO SURGICAL INTERVENTION WAS REQUIRED TO REPAIR THE DAMAGE TO THE PORT SITES. DERMABOND WAS APPLIED TO THE PORT-SITES AS PART OF THE POST-OPERATIVE CARE FOR THE INCISIONS. DURING THE SURGICAL PROCEDURE, A PK DISSECTING FORCEPS INSTRUMENT AND MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WERE USED DURING THE SURGICAL PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, SHE WAS PRESENT DURING THE SURGICAL PROCEDURE AND INDICATED THAT DURING THE SURGICAL PROCEDURE, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES WAS OBSERVED. IN ADDITION, ARCING FROM THE CAUTERY INSTRUMENTS USED WAS NOT OBSERVED. THE SITE USED A GYRUS ELECTROSURGICAL GENERATOR (ESU) FOR THE PK DISSECTING FORCEPS INSTRUMENT AND A CONMED ESU WAS USED FOR THE MCS INSTRUMENT. THE SETTINGS FOR THE GYRUS ESU WERE NOT PROVIDED; HOWEVER, THE CAUTERY SETTINGS FOR THE MCS INSTRUMENT WERE 30 WATTS (CUT/COAG). THE GROUNDING PAD WAS PLACED ON THE PATIENT'S LEFT THIGH. ON (B)(4) 2014, THE ISI CSR SPOKE TO THE SITE'S ROBOTICS COORDINATOR REGARDING THE REPORTED EVENT. ACCORDING TO THE ROBOTICS COORDINATOR, THE SITE PERFORMED AN INTERNAL INVESTIGATION AND IT WAS DETERMINED THAT THE PORT SITE BURNS SUSTAINED BY THE PATIENT WERE UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT OCCURRED DUE TO AN ISSUE WITH THE SITE'S ESU. THE CSR WAS TOLD BY THE ROBOTICS COORDINATOR THAT THEY REPLACED THE ESU AND HAVE HAD NO OTHER OCCURRENCES OF THE ISSUE. ON (B)(4) 2014, AN ISI FIELD SERVICE ENGINEER (FSE) EVALUATED THE SITE'S SYSTEM. THE FSE WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE. ELECTRICAL SAFETY TESTING OF THE PATIENT SIDE CART (PSC) AND THE PATIENT SIDE MANIPULATOR (PSM) ARMS PASSED. A GROUND ISOLATION PROCEDURE BETWEEN THE CANNULA MOUNTS ON THE PSMS WAS PERFORMED. TESTING OF THE SYSTEM USING THE SITE'S CANNULAS, INSTRUMENTS, CABLES AND ESUS IN AN ATTEMPT TO REPRODUCE ARCING OR ELECTRICAL MALFUNCTIONING TO THE CANNULA OR PSMS AT THE POINT IN WHICH THE PATIENT WAS BELIEVED TO HAVE BEEN BURNED WAS NOT OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362066 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 N10140409 209

    Patients

    Seq Age Sex Outcome Treatment
    1