BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSI THORAX-DRAINAGE SET

    MDR report key: 10944893 · Received December 4, 2020

    Report

    Report Number
    9610612-2020-00857
    Event Type
    Injury
    Date Received
    December 4, 2020
    Date of Event
    November 4, 2020
    Report Date
    February 24, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    LRW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY X PROBABILITY OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. 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 THERE IS 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 5062020 - SUSI THORAX-DRAINAGE SET. ACCORDING TO THE COMPLAINT DESCRIPTION, AFTER THE SKIN INCISION, THE SCISSORS INCLUDED IN THE SET WERE USED TO SPREAD THE INTERCOSTAL MUSCLES. THE SCISSORS BROKE IN THE AREA OF THE HINGE WHEN THEY WERE OPENED EASILY AND WITH MINIMAL RESISTANCE. ONE OF THE TWO CUTTING BLADES ADHERED ONLY MINIMALLY TO THE METAL, SO THAT A CAREFUL RETRACTION WAS STILL POSSIBLE WITHOUT ANY PROBLEMS. THE HINGE IS BROKEN OFF ON ONE SIDE. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408313 SUSI THORAX-DRAINAGE SET SUSI SETS AND KITS LRW AESCULAP AG 5062020 20C02844

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention