BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 3821689 · Received May 20, 2014

    Report

    Report Number
    2955842-2014-03099
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND A PIECE OF WHITE MATERIAL CAUGHT IN BETWEEN THE GRIP CABLE AND YAW PULLEY. THE SAME MATERIAL WAS ALSO FOUND AT THE BACKEND OF THE INSTRUMENT AS WELL ON THE GRIP CABLE NEAR THE CLAMPING PULLEY. THE MATERIAL HAD NO EFFECT ON THE INSTRUMENT. THE INSTRUMENT WORKED NORMALLY AND EXPERIENCED NO FRICTION WHEN MANUALLY ARTICULATING THE WRIST. AN ADDITIONAL FINDING WERE DEEP SCRATCHES ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE LOCATED .9575 ABOVE THE MAIN TUBE AND PROXIMAL CLEVIS INTERFACE. THE SCRATCHES VARIED IN LENGTH AND WERE NOT AXIALLY ALIGNED WITH THE TUBE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SACROCOLPOPEXY PROCEDURE, A PIECE OF SUTURE WAS STUCK IN THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. NOTHING REPORTEDLY FELL 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
    300786 MARYLAND BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10130211 117

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR