BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3120769 · Received May 20, 2013

    Report

    Report Number
    3005075853-2013-02433
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED. WE DID NOT RECEIVE A BATCH NUMBER OR LOT NUMBER SO THEREFORE WE WERE UNABLE TO REVIEW THE MANUFACTURING RECORDS

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: PHOTO ANALYSIS. WE WERE UNABLE TO ANALYZE THE SAMPLE UTILIZED IN THE REPORTED EVENT AS THE INSTRUMENT WAS NOT RETURNED TO US. THERE WAS A SET OF PHOTOGRAPHS SUBMITTED ON A REPORT. THERE ARE PICTURES OF TWO DIFFERENT DEVICES. DEVICE A APPARENTLY HAD THE UPPER JAW OF THE DEVICE DETACHED, AND THE ELECTRODE AND THE CERAMIC DETACHED FROM THE JAWS OF THE DEVICE. THE SECOND DEVICE HAD THE ELECTRODE SEPARATED FROM THE JAW, BUT STILL ATTACHED TO THE ELECTRODE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, THE ELECTRODE PEELED AWAY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. COMPUTERIZED TOMOGRAPHIC EXAMINATION WAS PERFORMED AT END OF THE OPERATION, CT FEATURES SUGGESTED THE EXISTENCE OF THE BROKEN PIECE. THE DOCTORS FOUND THE BROKEN PIECE AND IT WAS RETRIEVED FROM THE PATIENT IN ABOUT AN HOUR. COMPUTERIZED TOMOGRAPHY WAS PERFORMED AGAIN, THERE WAS NO FINDINGS LIKE THE BROKEN PIECE. WE ARE PRESENTLY CHECKING DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221873 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1