BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE INSERT

    MDR report key: 3170389 · Received June 14, 2013

    Report

    Report Number
    2955842-2013-02172
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, ISI CONTACTED THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE NURSE INDICATED THAT THE HARMONIC ACE INSERT TIP FELL INSIDE THE PATIENT AND IT WAS RETRIEVED. SHE INDICATED THAT NO INJURY TO THE PATIENT OCCURRED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THE HARMONIC ACE INSTRUMENT AND THE HARMONIC ACE INSERT WERE DISPOSED OF BY THE HOSPITAL; THEY WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED UF/IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: HARMONIC TIP BROKE OFF, BUT IT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270450 HARMONIC ACE INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272 M10130119

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR DA VINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIE