BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON STEEL SCALPEL BLADES #11

    MDR report key: 11398726 · Received March 2, 2021

    Report

    Report Number
    9610612-2021-00112
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    October 22, 2020
    Report Date
    July 14, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    GES
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE LACK OF ONFORMATION IT IS NOT POSSIBLE TO CHECKED THE DEVICE HISTORY RECORDS. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BB511-CARBON STEEL SCALPEL BLADES #11. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SCALPEL BLADE NO. 11 BBRAUN (LOT: K9356329), PRESENTS LOSS OF THE WIRE IN ADVANCE, REQUIRING EXTRA CONSUMPTION. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295391 CARBON STEEL SCALPEL BLADES #11 GENERAL SURGICAL INSTRUMENTS GES AESCULAP AG BB511 K9356329

    Patients

    Seq Age Sex Outcome Treatment
    1