BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3833318 · Received May 27, 2014

    Report

    Report Number
    2955842-2014-03248
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE INITIAL REPORTER'S COMPLAINT. ONE GRIP WAS BENT CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A .025 OFFSET AT THE TIPS. THE BENT GRIP DID NOT EXHIBIT SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, LIKELY CAUSE OF BENDING REMAINS OVERLOADING AT THE TIP. FAILURE ANALYSIS CONCLUDED THAT BENT DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE INSTRUMENT MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SCRATCHES ARE NOT ALIGNED WITH THE TUBE AXIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE BLADE OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS TORN AND WAS IMPOSSIBLE TO USE. INTUITIVE SURGICAL, INC. CONTACTED THE SITE TO OBTAIN CLARIFICATION OF THE EVENT AND NOTED THAT THE BLADE WAS BENT NOT TORN AS ORIGINALLY DESCRIBED. NOTHING FELL INTO THE PATIENT AND THERE WAS NO REPORT OF PATIENT INJURY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311557 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M11140129

    Patients

    Seq Age Sex Outcome Treatment
    1