BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURSE STRING CLAMP

    MDR report key: 5032868 · Received August 21, 2015

    Report

    Report Number
    2916714-2015-00727
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Report Date
    February 23, 2016
    Manufacturer
    AESCULAP, INC.
    Product Code
    HXD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: 08/10/2015. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 EA323R PURSE STRING CLAMP. THE INSTRUMENT SHOWS NO VISIBLE DAMAGES. THIS INSTRUMENT IS MANUFACTURED ACCORDING TO THE FACTORY SAMPLE. TEST WITH SILK PAPER, ACCORDING TO THE TEST PAPER: THE SILK PAPER IS PUT INTO THE CLAMP, WHICH IS CLOSED COMPLETELY FOR AT LEAST 2 SECONDS. AFTER OPENING THE CLAMP, THE IMPRESSION OF THE LONGITUDINAL PROFILE MUST BE FULLY VISIBLE AND MUST NOT SHOW PERFORATION. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. BASED ON OUR INVESTIGATION THE FAILURE IS NOT MANUFACTURING RELATED. MOST LIKELY THE FAILURE IS HANDLING RELATED. THE INSTRUMENT DOESN'T SHOW ANY DEVIATIONS FROM THE SPECIFICATIONS. ALSO THE CARRIED OUT TEST WITH SILK PAPER WAS PASSED SUCCESSFULLY. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). AFTER PIERCING THE NEEDLE STRAIGHT THROUGH BOTH BRANCHES, OPENING THE CLAMP AND PULLING THE PURSE STRING SUTURE, IT WAS NOTICED THAT THE MUCOSA WAS ONLY PARTIALLY PUNCTURED AND THUS THERE IS A SEAM INSUFFICIENCY. (THE INSTRUMENT HAS BEEN USED TWICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555158 PURSE STRING CLAMP HXD AESCULAP, INC. EA323R 4505602136

    Patients

    Seq Age Sex Outcome Treatment
    1 Other