BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC MAYO-HEGAR NDL HOLDERHVYSERR205MM

    MDR report key: 5032865 · Received August 21, 2015

    Report

    Report Number
    2916714-2015-00730
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    June 3, 2015
    Report Date
    February 23, 2016
    Manufacturer
    AESCULAP, INC.
    Product Code
    HXK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 BM067R MAYO-HEGAR NEEDLE HOLDER . AN INVESTIGATION WAS PERFORMED VISUALLY. THE METAL INLAY OF ONE JAW WAS BROKEN OFF AND WAS NOT RETURNED FOR EVALUATION. THE BROKEN SEGMENT IS APPROXIMATELY 2 MM FROM THE TIP OF THE JAW. THE LABELING OF THE INSTRUMENT WAS NOT COMPLETED BY AESCULAP. ALSO THE SOLDER JOINT IS NOT TO AESCULAP STANDARDS. THE DEVICE APPEARS TO HAVE BEEN REPAIRED BY A FOREIGN COMPANY AND DOES NOT MEET AESCULAP STANDARDS. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. THE FAILURE RESULT IS USER RELATED, USING NON AUTHORIZED REPAIR SERVICE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(6) 2015. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). LOSS OF A PIECE OF THE JAWS OF THE NEEDLE HOLDER IN THE SURGICAL SITE DURING THE INTERVENTION. THE BROKEN PIECE WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554848 TC MAYO-HEGAR NDL HOLDERHVYSERR205MM HXK AESCULAP, INC. BM067R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other