BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC WIRE HOLDING FORCEPS LAT-JAW 170MM

    MDR report key: 8541699 · Received April 23, 2019

    Report

    Report Number
    9610612-2019-00293
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 23, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    HYA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE TC WIRE HOLDING FORCEPS. THE CUSTOMER STATED THAT TWO PRODUCTS WERE RECEIVED AND REJECTED. THE CRACKS WERE IDENTIFIED AT THE FACILITY UPON RECEIPT AND THE FORCEPS WERE NOT USED; A PICTURE REVEALED FRACTURES ON THE INSERTS. THERE WAS NO PATIENT INVOLVEMENT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335160 TC WIRE HOLDING FORCEPS LAT-JAW 170MM GENERAL SURGICAL INSTRUMENTS HYA AESCULAP AG LX176R 4510089589

    Patients

    Seq Age Sex Outcome Treatment
    1