BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS INSERT

    MDR report key: 3813296 · Received May 15, 2014

    Report

    Report Number
    2955842-2014-03003
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO FOLLOWING CONCLUSION: THE JAWS OF THE HARMONIC ACE CURVED SHEARS INSERT BROKE OFF THE INSTRUMENT AND FELL INTO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE INSERT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THE METALIC TIP OPPOSITE SIDE OF THE TEFLON PAD BROKEN AND 0.669 LONG PIECE WAS MISSING FROM THE HARMONIC INSERT. NO OTHER DAMAGE WAS FOUND. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, ISI ATTEMPTED TO SUBMIT THIS REPORT ON TIME WITHIN REPORTING TIMEFRAME; HOWEVER, THE ESG DOWNTIME THAT OCCURRED FROM (B)(4) 2014 3:43 PM EST THROUGH THURS (B)(4) 2014 3:00 AM EST PREVENTED ISI TO SUBMIT THIS REPORT ON TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SUPRACERVICAL HYSTERECTOMY PROCEDURE, THE JAWS OF THE HARMONIC ACE CURVED SHEARS INSERT BROKE OFF AND FELL INTO THE PATIENT. ACCORDING TO THE SURGEON, ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. CONTACTED THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING REPORTED EVENT AND OBTAINED FOLLOWING INFORMATION: THE BROKEN PIECES FROM HARMONIC ACE CURVED SHEARS INSERT WERE RETRIEVED LAPAROSCOPICALLY. NO ADDITIONAL SURGICAL PROCEDURES AND NO POST-OPERATIVE TEST WERE REQUIRED TO RETRIEVE THE PIECES. THE SURGEON WAS SEALING THE CERVIX WHEN THE INSERT TIP BROKE OFF. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO PHYSICAL DAMAGE WAS FOUND. THE INSTRUMENT AND THE INSERT WERE IN USE FOR ABOUT 15 MINUTES. THERE WAS NO ALLEGATION OF PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289354 HARMONIC ACE CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272-02 M10140106

    Patients

    Seq Age Sex Outcome Treatment
    1