BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3071505 · Received April 22, 2013

    Report

    Report Number
    2955842-2013-01347
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING NOTED A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY EXCESSIVE DAMAGE. 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.

    Description of Event or Problem · 1

    DURING A DA VINCI SI SURGICAL PROCEDURE, THE USER FACILITY REPORTEDLY IDENTIFIED A BROKEN CABLE ON THE PROGRASP FORCEPS INSTRUMENT. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172171 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10121212 743

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES