BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3141065 · Received June 3, 2013

    Report

    Report Number
    2955842-2013-01949
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS INCIDENT. THE CSR INDICATED THAT HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE WHEN THE INJURY OCCURRED TO THE PATIENT. THE CSR INDICATED THAT HE WAS TOLD BY THE SURGEON, THAT HE NOTED THAT WHILE WORKING ON ANOTHER AREA OF THE PATIENT'S ANATOMY, THE SURGEON NOTED THAT THE PATIENT WAS BLEEDING FROM THE ILIAC VEIN. THE SURGEON CLAMPED THE PATIENT'S VESSEL USING A BULLDOG CLAMP AND REPAIRED THE AFFECTED AREA WITH THE APPLICATION OF SUTURES USING AN ENDOWRIST NEEDLE DRIVER INSTRUMENT. EXAMINATION OF THE PATIENT'S VESSEL BY THE SURGEON DETERMINED THE PATIENT HAD SUSTAINED A THERMAL INJURY. THE CSR INDICATED THAT THE SURGEON INITIALLY BELIEVED THAT THE INJURY TO THE PATIENT WAS UNRELATED TO A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND ACCESSORIES, BUT RATHER, HE (SURGEON) HAD INADVERTENTLY CAUSED DAMAGE TO THE PATIENT'S VESSEL WHILE PERFORMING LYMPH NODE DISSECTION OR WHILE OPENING THE PATIENT'S PELVIC SIDE WALL TO ACCESS THE UTERINE ARTERY. UPON RECEIPT OF THE ISI'S PRODUCT NOTIFICATION LETTER REGARDING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THE SURGEON NOTIFIED THE CSR AND INDICATED THAT THE DAMAGE TO THE PATIENT'S VESSEL MAY HAVE OCCURRED AS A RESULT OF CAUTERY ENERGY COMING FROM A POSSIBLE CRACK IN THE MCS INSTRUMENT. THE CSR INDICATED THAT DURING THE SURGICAL PROCEDURE, ARCING FROM THE MCS INSTRUMENT WITH THE TIP COVER ACCESSORY INSTALLED WAS NOT OBSERVED. THE CSR DOES NOT KNOW IF THE SITE PERFORMED AN INSPECTION OF THE MCS INSTRUMENT OR TIP COVER PRIOR TO USE. AN INSPECTION OF MSC INSTRUMENT AND TIP COVER AFTER USE WAS NOT PERFORMED BY THE SURGICAL STAFF, SINCE IT WAS INITIALLY BELIEVED THAT THE INJURY TO THE PATIENT OCCURRED AS A RESULT OF USER ERROR. THE CSR INDICATED THAT THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND TO THE BEST OF HIS KNOWLEDGE THE PATIENT RECOVERED AND THERE WAS NO REPORT TO HIM BY THE SITE THAT THE PATIENT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. AT THIS TIME, ISI IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT AS THE INSTRUMENT IS NOT AVAILABLE FOR ANALYSIS. ISI HAS CONTACTED THE SURGEON SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL, INC. RECEIVED ADDITIONAL INFORMATION FROM THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT WAS DOING WELL WITHOUT ANY PROBLEMS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 AND DID NOT RETURN TO THE HOSPITAL DUE TO COMPLICATIONS. THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE TO THE INSTRUMENT NOTED BY THE NAKED EYE. THE ELECTROSURGICAL UNIT SETTING WAS 30 COAG. REPORTEDLY, THE PATIENT WAS SCHEDULED FOR A VENOUS ULTRASOUND TO CONFIRM THAT THERE WAS NO STENOSIS. THE RESULTS OF THE ULTRASOUND WERE PENDING. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT'S EXTERNAL ILIAC VEIN WAS DAMAGED. THE PATIENT'S VESSEL WAS REPAIRED LAPAROSCOPICALLY AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. REPORTEDLY, THE SURGEON BELIEVES THAT THE DAMAGE TO THE PATIENT'S VESSEL MAY HAVE OCCURRED AS RESULT OF THERMAL SPREAD FROM A MICRO CRACK IN THE MONOPOLAR CURVED SCISSORS INSTRUMENT. THE SITE DISCARDED THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243784 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention DA VINCI SI SURG SYST., MCS TIP CVR, ACCSS & ESU.