BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS

    MDR report key: 2920149 · Received December 11, 2012

    Report

    Report Number
    2955842-2012-01261
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 13, 2012
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE PITCH CABLE IS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP IS MISSING FROM THE CLEVIS. THE CLEVIS DOES NOT EXHIBIT EXCESSIVE DAMAGE. THE INSTRUMENT HAS 6 USES REMAINING. INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, IT WAS NOTED THAT "A BROKEN CABLE" WAS VISIBLE ON THE PK DISSECTING FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK DISSECTING FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT, NAY NAY INTUITIVE SURGICAL, INC. 420227-03 M10120912 380

    Patients

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