BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIP COVER ACCESSORY

    MDR report key: 5251044 · Received November 25, 2015

    Report

    Report Number
    2955842-2015-01443
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    September 21, 2015
    Report Date
    October 30, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IN ADDITION, BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. ON 11/19/2015, ISI CONTACTED THE INITIAL REPORTER, A NURSE FROM THE SITE'S QUALITY AND SAFETY DEPARTMENT. HOWEVER, THE INITIAL REPORTER WAS UNWILLING TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THE SYSTEM LOGS ALSO REVEAL THAT THE MCS INSTRUMENT USED DURING THE REPORTED DA VINCI PARTIAL NEPHRECTOMY HAS BEEN USED IN MULTIPLE SUBSEQUENT SURGICAL PROCEDURES WITH NO REPORTED ISSUES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT'S GALLBLADDER WALL WAS ALLEGEDLY BURNED AFTER ELECTRICAL ENERGY ARCED THROUGH A MCS TIP COVER ACCESSORY INSTALLED ON A MCS INSTRUMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5056741 WITH THE FOLLOWING EVENT DESCRIPTION: DURING A RIGHT ROBOTIC PARTIAL NEPHRECTOMY, A PROTECTION SCISSOR TIP DEVELOPED A HOLE DURING SURGERY. ONCE THE INSTRUMENT WAS USED AN ELECTRICAL ARC DEVELOPED AND BURNED THE GALLBLADDER WALL. ANOTHER PHYSICIAN WAS NOTIFIED TO CONSULT IN THE OPERATING ROOM AFTER PARTIAL NEPHRECTOMY WAS PERFORMED. HE OBSERVED THE GALLBLADDER. NO BILE WAS SEEN AT PRESENT TIME. A DRAIN WAS PLACED TO DRAIN ANY FLUID FROM THE KIDNEY OR GALLBLADDER AND F/U ASSESSMENT WITH PT WILL OCCUR. THERE IS A VISIBLE BURN/HOLE IN SOME OF THE PRODUCT. CONCOMITANT MEDICAL: PN 500907-03 VALLEYLAB REM POLYADHESIVE ADULT, PATIENT RETURN ELECTRODE ALSO USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782047 TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180 M10150721

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention