BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETIT-POINT O-HEGAR NH 5 SERR

    MDR report key: 5992751 · Received October 1, 2016

    Report

    Report Number
    2523190-2016-00155
    Event Type
    Malfunction
    Date Received
    October 1, 2016
    Report Date
    August 31, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 9/20/16 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - FAILURE ANALYSIS CANNOT BE PERFORMED BASED ON THE LACK OF INFORMATION PROVIDED BY THE CUSTOMER. THE INSTRUMENT WAS NOT RETURNED FOR FURTHER EVALUATION.CUSTOMER STATED ITEM IS NOT AVAILABLE FOR PICKUP . DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTIONS: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS A PIECE OF THE NEEDLE HOLDER BROKE OFF WHILE DOING A POSTERIOR ENTEROCELE. BOTH PIECES THOUGHT TO BE RECOVERED. NO HARM DONE. UPDATE 9/6/16 CUSTOMER HAS NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643944 PETIT-POINT O-HEGAR NH 5 SERR N/A FHQ INTEGRA YORK, PA INC. E4

    Patients

    Seq Age Sex Outcome Treatment
    1