BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3011213 · Received March 19, 2013

    Report

    Report Number
    2955842-2013-00894
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 20, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH UP CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT WRIST WERE NOT DAMAGED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS MAIN TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE 0.075 - 0.170 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS.

    Description of Event or Problem · 1

    RECEIVED MEDWATCH FORM FROM THE CUSTOMER. ACCORDING TO THE MDR REPORT, PK DISSECTOR INSPECTED PRIOR TO USE IN PT. PK DISSECTOR NOTICE BY SURGEON THAT IT HAS FRAYED AN HOUR AFTER INITIAL USAGE. INSTRUMENT MALFUNCTION BY NOT BEING ABLE TO BE REMOVED FROM THE PORT. THE PORT WITH INSTRUMENT IN PLACE REMOVED FROM PATIENT. ANGLE OF DISSECTOR MALFUNCTION. WHEN REMOVED FROM PORT (OUTSIDE OF BODY) IT WAS NOTICED THAT A CABLE HAD BROKE. SMALL CABLE PIECE FOUND INSIDE THE TROCAR. X-RAY TAKEN PER POLICY. X- RAY TAKEN = NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114275 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120830 208

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES