BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUVACOLLIN INTESTINAL FORCEPS195MM

    MDR report key: 6421913 · Received March 21, 2017

    Report

    Report Number
    9610612-2017-00128
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Report Date
    May 9, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: UNITED KINGDOM. IT WAS REPORTED THAT DETAILS OF AN INCIDENT OF A DEVICE TEST CONSIST OF BURRS/FRAGMENTS AND GAPS ON THE SERRATIONS. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00127, 9610612-2017-00129, 9610612-2017-00133, 9610612-2017-00134.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT VISUALLY. ACCORDING TO THE STATEMENT OF THE R AND D DEPARTMENT, THE FORCEPS ARE ACCORDING TO THE QSTD STANDARD ((B)(4)). "THE SLIGHT MISALIGNMENT BETWEEN THE TOOTHING IS A VISUAL DEFECT. THERE ARE NO ADDITIONAL RISKS FOR THE PATIENT OR USER." BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE INSTRUMENTS ARE ACCORDING TO THE SPECIFICATIONS. CORRECTIVE ACTION: ACCORDING TO SOP (B)(4) A CAPA IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205453 DUVACOLLIN INTESTINAL FORCEPS195MM GENERAL SURGICAL INSTRUMENTS HTD AESCULAP AG EA041R 4508148321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other