BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 2960715 · Received January 25, 2013

    Report

    Report Number
    2955842-2013-00304
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 28, 2012
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE ALLEGED COMPLAINT THAT THE INSTRUMENT'S TIP WOULD NOT STRAIGHTEN COULD NOT BE CONFIRMED. THE DRIVE CABLES AT THE INSTRUMENT'S WRIST WERE INTACT AND UNDAMAGED. THE WRIST WAS STRAIGHT WHEN INPUT DISC DOGS WERE ALL ALIGNED HORIZONTALLY. THE GRIPS WERE ABLE TO OPEN/CLOSE FINE WHEN INPUT DISCS WERE MANUALLY ROTATED. AN ADDITIONAL OBSERVATION THAT WAS NOT REPORTED BY THE SITE WAS TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .070" - .300" IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. EVIDENCE IS NOT CONCLUSIVE, BUT THE DAMAGE MIGHT HAVE BEEN CAUSED BY MISHANDLING/MISUSE. PER THE CUSTOMER, AT THE TIME OF THE REPORTED EVENT, NOTHING FELL INTO A PT DURING A SURGICAL PROCEDURE. 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. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI STANDARD TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF ALLEGED THAT THE TIP OF A TENACULUM FORCEPS INSTRUMENT WOULD NOT STRAIGHTEN. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36305 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT, NAY NAY INTUITIVE SURGICAL, INC. 400207-08 M101110818 358

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SURGICAL SYSTEM| ACCESSORIES| ESU