BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 11426396 · Received March 7, 2021

    Report

    Report Number
    9610612-2021-00122
    Event Type
    Injury
    Date Received
    March 7, 2021
    Date of Event
    February 4, 2021
    Report Date
    September 8, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    FZP
    UDI-DI
    04046955241026
    PMA / PMN Number
    K202124
    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 4(5) X PROBABILITY OF OCCURRENCE 2(5)) 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 A PRODUCT SAFETY CASE AND A FIELD SAFETY CORRECTIVE ACTION (PSC-2020-033 AND FSCA-255) WERE INITIATED. ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH THIS CASE. A PRODCUT RECALL WAS INITIATED. THE DEVICE IS NOT SOLD NOR MARKETED ANYMORE.

    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 FC700SU PAS PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PASPORT DIDN'T TRIGGER PROPERLY DURING SURGERY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325882 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM ANASTOMOSIS DEVICES FZP AESCULAP AG FC700SU 52646001 04046955241026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention