BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3997291 · Received August 10, 2014

    Report

    Report Number
    2955842-2014-04851
    Event Type
    Malfunction
    Date Received
    August 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIPS OF THE INSTRUMENTS GRIPS WERE BENT. ONE GRIP WAS BENT, CAUSING A SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A .211 OFFSET AT THE TIPS. THE BENT GRIP DID NOT EXHIBIT SEPARATION OF THE YAW PULLEY AND PULLEY COVER; HOWEVER, THE LIKELY CAUSE OF BENDING IS OVERLOADING AT THE TIP. FAILURE ANALYSIS CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING / MISUSE. AN ADDITIONAL OBSERVATION NOT REPORTED WAS THE PITCH DOWN AND UP CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. AN ADDITIONAL OBSERVATION NOT REPORTED WERE VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .063 - .213 IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN CABLES AND TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    THE PK DISSECTING FORCEPS INSTRUMENT WAS USED DURING A DA VINCI HYSTERECTOMY PROCEDURE BUT NO DESCRIPTION OF THE ISSUE WAS PROVIDED. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO A PATIENT. 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
    474660 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120926 452

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR