BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOC PLUS ENDOTOUCH APPL 13" CVD

    MDR report key: 4909598 · Received July 13, 2015

    Report

    Report Number
    1044475-2015-00241
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    May 28, 2015
    Report Date
    June 15, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GEF
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD (DHR) REVIEW FOR THE INSTRUMENT IN QUESTION WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. THE RETURNED INSTRUMENT WAS EVALUATED AND IT WAS FOUND THAT THE BACK OF THE DRIVE ROD IS BROKEN OFF THAT CONNECTS TO THE HANDLE AND THAT THE INSTRUMENT WILL NOT FUNCTION PROPERLY THUS VALIDATING THE COMPLAINT. WE ARE UNABLE TO DETERMINE WHAT CAUSED THE ALLEGED DEFECT, BUT MIS-HANDLING AT THE END USER'S LOCATION IS SUSPECTED. PARTS WERE 100% VISUALLY INSPECTED AND TESTED AT THE MANUFACTURING FACILITY BEFORE INSTRUMENTS WERE SENT TO CUSTOMER. NO IRREGULARITIES WERE FOUND AND/OR REPORTED AT THE TIME OF INSPECTION AND ASSEMBLY OF THE PRODUCT AS THIS IS A STANDARDIZED PROCESS FOR ALL INSTRUMENTS MANUFACTURED AT THIS FACILITY. NO CORRECTIVE ACTION REQUIRED AT THIS TIME. CONCLUSION: NO CONCLUSION CODE AVAILABLE THAT COULD ACCURATELY DESCRIBE THAT THE COMPLAINT WAS CONFIRMED, BUT THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    ALLEGED EVENT: DURING BILE SURGERY SOMETHING IN THE HANDLE OF THE APPLIER BROKE. A CLIP FELL INTO THE PATIENT'S BODY AND IT WAS REMOVED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: DURING BILE SURGERY SOMETHING IN THE HANDLE OF THE APPLIER BROKE. A CLIP FELL INTO THE PATIENT'S BODY AND IT WAS REMOVED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453454 HOC PLUS ENDOTOUCH APPL 13" CVD APPLIER GEF TELEFLEX MEDICAL 06F1148402

    Patients

    Seq Age Sex Outcome Treatment
    1