BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 11653038 · Received April 12, 2021

    Report

    Report Number
    9610612-2021-00287
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 10, 2021
    Report Date
    November 9, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: VISUAL INVESTIGATION: THE DEVICE IS IN A USED CONDITION. 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 3 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. BASED UPON THE INVESTIGATIONS RESULTS PRODUCT SAFETY CASE(PSC-2020-033 ) AND FIELD SAFETY CORRECTIVE ACTION(FSCA-255) WERE INITIATED. ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH THIS CASE. A PRODUCT RECALL WAS INITIATED. PRODUCT 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, NO ANASTOMOSIS COULD BE PERFORMED. IT WAS REPORTED THAT PPS WAS USED FOR OPCAB. BUT SINCE THE PPS BODY COULD NOT BE PULLED OUT AFTER THE ANASTOMOSIS, THE SURGEON CONFIRMED THE ROOT OF ANASTOMOSIS SITE WITH FORCEPS. AND PPS BODY WAS ABLE TO PULL OUT. HOWEVER, WHEN THE SURGEON SUBSEQUENTLY CONFIRMED THE ANASTOMOTIC SITE, BLEEDING OCCURRED WITH THE OUTER FLANGE WARPED UP BY ABOUT 45 ° TO 50 °. PROBABLY THE OUTER FLANGE AND INNER FLANGE STOPPED JUST BEFORE THE DETACHMENT. AFTER THAT REMOVED THE STAPLER AND SVG USING A SIDE CLAMP, AND PERFORMED A CENTRAL ANASTOMOSIS BY HAND-SEWN INTO THE HOLE MADE BY PPS. 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
    551231 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM ANASTOMOSIS DEVICES FZP AESCULAP AG FC700SU 52627199 04046955241026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention