BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2162415 · Received July 14, 2011

    Report

    Report Number
    3005075853-2011-02883
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL ANALYSIS INFORMATION THE REGIONS AROUND THE PACKAGE SEAL WERE ANALYZED USING AN FTIR SPECTROMETER. THE FTIR CAN IDENTIFY ORGANIC COMPOUNDS BY PASSING AN IR BEAM INTO THE SAMPLE AND MEASURING THE WAVELENGTH OF THE LIGHT THAT IS ABSORBED BY THE MATERIAL. BY COMPARING THE SPECTRA, A COMPARISON CAN BE MADE BASED UPON THE RELATIVE ABSORBANCE AND REFLECTANCE ACROSS WAVELENGTHS, CORRESPONDING TO VARIOUS FUNCTIONAL ORGANIC GROUPS AND BONDS AT KNOWN FREQUENCIES. SUMMARY: THE FTIR SPECTRA FOR THE DELAMINATED AREAS SHOW VERY LITTLE TO NO DIFFERENCE BETWEEN THE BASE MATERIALS (TYVEK, PETG) AND THE AREAS IN QUESTION. THERE ARE EXTREMELY SLIGHT DIFFERENCES IN THE DELAMINATED AREAS WHICH POSSIBLY COULD BE INDICATIVE OF AN ALIPHATIC HYDROCARBON, HOWEVER, THIS MIGHT BE VARIATION IN THE BASE MATERIALS THEMSELVES AND/OR THE ADHESIVE. THERE DOES NOT APPEAR TO BE ANY SOLVENT OR CONTAMINATION BEYOND THIS, HOWEVER ANY VOLATILE MATERIAL COULD HAVE DISSIPATED BY THE TIME OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). PACKAGING ONE PRIMARY PACKAGE WAS RECEIVED WITH NO SALES UNIT CARTON. THE DEVICE WAS RETURNED WITH THE PRIMARY PACKAGE PREVIOUSLY OPENED. THE TYVEK WAS SEPARATED FROM BLISTER. FURTHER VISUAL INSPECTION INDICATED THAT THERE WERE TRANSPARENT AREAS ON THE SEAL, CONFIRMING THAT SEAL VOID WAS PRESENT. THE REASON OF THE SEAL VOID IS UNKNOWN AND UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BEFORE USE ON THE PATIENT, IT WAS NOTED THAT THE BLISTER WAS OPEN AND IT LOOKED LIKE THE "GLUE" WAS NOT OKAY. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK H90U2U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE