BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 1914612 · Received December 3, 2010

    Report

    Report Number
    2955842-2010-00526
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS RETURNED WITH A PIECE OF THE DISTAL CLEVIS DETACHED. THE BROKEN PIECE WAS ALSO RETURNED ALONG WITH THE INSTRUMENT. ONE DISTAL CLEVIS EAR IS BROKEN OFF AT ITS BASE. THE BROKEN PIECE IS APPROXIMATELY .300 X .235 AND IS ON THE OPPOSITE SIDE AS THE CONDUCTOR WIRE AND CAP. ENGINEERING CONCLUDED THAT DAMAGE TO THE INSTRUMENT WAS MOST LIKELY DUE TO TIP OVERLOADING. NO OTHER DAMAGE WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, HOWEVER, UPON FOLLOW UP WITH THE SITE BY THE FIELD SERVICE ENGINEER, THE SITE REPORTED THAT THE TIP OF THE INSTRUMENT WAS IN AN OPEN POSITION WHILE ATTEMPTING TO REMOVE THE INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. IT HAS BEEN DETERMINED THAT DAMAGE TO THE INSTRUMENT WAS CAUSED BY IMPROPER POSITIONING OF THE INSTRUMENT TIP AND EXCESSIVE FORCE WHILE ATTEMPTING TO REMOVE THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S MYOMECTOMY PROCEDURE, WHILE ATTEMPTING TO REMOVE THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT FROM THE PATIENT SIDE MANIPULATOR (PSM), THE INSTRUMENT BECAME STUCK. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE), THE SITE WAS INSTRUCTED TO REPOSITION THE PSM TO VIEW THE INSTRUMENT TIP. AFTER REPOSITIONING THE PSM, THE SURGICAL STAFF OBSERVED THAT THE TIP OF THE PCH INSTRUMENT WAS POSITIONED AT AN ACUTE ANGLE, WHICH PREVENTED REMOVAL OF THE INSTRUMENT. AFTER STRAIGHTENING THE INSTRUMENT TIP, THE SITE WAS ABLE TO REMOVE THE INSTRUMENT. UPON INSPECTION OF THE PCH INSTRUMENT BY THE SURGICAL STAFF, IT WAS OBSERVED THAT A YELLOW PIECE FROM THE INSTRUMENT WAS MISSING. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE TO LOCATE AND REMOVE THE BROKEN INSTRUMENT PIECE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-04 S10091228 250

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SYSTEM, ACCESSORIES & ESU