BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3872878 · Received June 13, 2014

    Report

    Report Number
    2955842-2014-03644
    Event Type
    Other
    Date Received
    June 13, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT INVOLVED WITH THIS COMPLAINT WAS RETURNED TO ISI AND EVALUATED. ONE OF THE INSTRUMENT'S GRIPS-TIPS WAS FOUND TO BE BENT WHICH WAS CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. A 0.049 OFFSET AT THE TIPS, INDICATING OVERLOADING AT THE TIP, WAS OBSERVED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. FA CONCLUDED THAT THE BENT GRIP-TIP DAMAGE MAY HAVE BEEN LIKELY DUE TO MISHANDLING/MISUSE. THE INSTRUMENT'S PITCH CABLE WAS ALSO FOUND TO BE FRAYED AT THE DISTAL IDLER. NO DAMAGE WAS FOUND ON THE INSTRUMENT'S CLEVIS. IN ADDITION, SCRATCHES WERE FOUND ON THE INSTRUMENT'S DISTAL PULLEY AND ON THE DISTAL END OF MAIN TUBE. THE SCRATCH ON THE INSTRUMENT'S MAIN TUBE EXHIBITED LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCH WAS SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ALSO, BOTH OF THE INSTRUMENT'S BIPOLAR PINS WERE OBSERVED TO BE BENT. FA CONCLUDED THAT THE BENT GRIP-TIP DAMAGE AND BENT BIPOLAR PINS MAY HAVE BEEN LIKELY DUE TO MISHANDLING/MISUSE. 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. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI NEPHRECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER THE RESIDENT MANUALLY INSERTED A MARYLAND BIPOLAR FORCEPS INSTRUMENT AND BLEEDING ENSUED. HOWEVER, AT THIS TIME, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY PROCEDURE, A RESIDENT ASSISTING THE SURGEON WAS HAVING DIFFICULTY INSERTING A MARYLAND BIPOLAR FORCEPS INSTRUMENT USING PATIENT SIDE MANIPULATOR 2 (PSM2). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE RESIDENT ATTEMPTED MULTIPLE TIMES UNSUCCESSFULLY TO ADVANCE THE INSTRUMENT. DURING THE PROCESS OF ATTEMPTING TO MANUALLY ADVANCE THE INSTRUMENT, THE RESIDENT INJURED ONE OF THE PATIENT'S VESSELS WHICH RESULTED WITH AN ESTIMATED BLOOD LOSS OF 500 ML. THE BLEEDING WAS CONTROLLED. HOWEVER, NO DEFINITIVE VESSEL INJURY WAS FOUND. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT INVOLVED WITH THIS COMPLAINT. ACCORDING TO THE OPERATIVE REPORT, THE RESIDENT WAS HAVING DIFFICULTY INSTALLING A MARYLAND BIPOLAR FORCEPS INSTRUMENT INTO PSM2. THE OPERATIVE REPORT INDICATED THAT DUE TO A MALFUNCTION OF PSM2 AND AFTER MULTIPLE ATTEMPTS WERE MADE UNSUCCESSFULLY TO INSTALL THE MARYLAND BIPOLAR FORCEPS INSTRUMENT, THE RESIDENT MANUALLY ADVANCED THE INSTRUMENT. AT THAT POINT, BLEEDING WAS OBSERVED. THE SURGEON USED A DEBAKEY FORCEPS LAPAROSCOPIC INSTRUMENT TO GRASP AREA WHERE BLEEDING WAS NOTED. THE SURGEON INITIALLY BELIEVED THAT POSSIBLY A MESENTERIC VESSEL, THE RENAL ARTERY, THE AORTA, OR THE INFERIOR VENA CAVA (IVC) WAS INJURED DURING THE RESIDENT'S ATTEMPT TO MANUALLY ADVANCE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. IN ORDER TO FIND THE SOURCE OF THE BLEEDING, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI NEPHRECTOMY PROCEDURE TO OPEN SURGERY. VASCULAR SURGERY WAS CONSULTED. NO INJURY WAS FOUND TO THE PATIENT'S AORTA, MESENTERIC VESSELS, OR RENAL ARTERY. VASCULAR SURGERY NOTICED AN AREA OVER THE IVC THAT MAY HAVE POTENTIALLY BEEN THE SITE OF INJURY. THE SURGICAL STAFF APPLIED A HEMOSTATIC AGENT TO THE AREA AND NO FURTHER BLEEDING WAS OBSERVED. THE RISK MANAGER STATED THAT THERE WAS NO DEFINITIVE SOURCE OF WHERE THE BLEEDING CAME FROM. THE RISK MANAGER STATED THAT THE NEPHRECTOMY PROCEDURE WAS SUCCESSFULLY COMPLETED VIA OPEN SURGERY. THE PATIENT DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 AND NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. ON (B)(6) 2014, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) ASSIGNED TO THE SITE. THE CSR INDICATED THAT HE SPOKE TO VARIOUS SURGICAL STAFF MEMBERS WHO WERE PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGICAL STAFF INFORMED HIM THAT THE BLEEDING OCCURRED AFTER THE RESIDENT MANUALLY ADVANCED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WHILE PRESSING THE CLUTCH BUTTON. THE CSR ALSO INDICATED THAT THE SITE CONCLUDED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE AND THE PATIENT'S INJURY WAS DUE TO USER-ERROR BY THE RESIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349985 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10130716 154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R