BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SCISSORS RED 180MM

    MDR report key: 7003773 · Received November 6, 2017

    Report

    Report Number
    9610612-2017-00539
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 13, 2017
    Report Date
    February 5, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    HRR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY THE RESPONSIBLE SUPPLIER QUALITY MANAGER. AFTER REVIEWING THE TEST PLAN, THE SCISSORS FOUND TO BE ACCORDING RO THE SPECIFICATION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. 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 THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONAL: BASED ON THE QUALITY STANDARDS AND THE DHR-REVIEW, WE EXCLUDE A MATERIAL OR MANUFACTURING CAUSED ERROR. IN GENERAL, TOO MUCH PRESSURE ON THE SKIN DURING CUTTING CAN CAUSE ABRASION. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782198 UNIVERSAL SCISSORS RED 180MM UNIVERSAL, BANDAGE, PLASTER SCISSOR HRR AESCULAP AG BC980R 4507471190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other