BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERAGON BIPOLAR

    MDR report key: 10209320 · Received June 29, 2020

    Report

    Report Number
    9611102-2020-00009
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 2, 2020
    Report Date
    June 22, 2020
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HET
    UDI-DI
    04055207026526
    PMA / PMN Number
    K033177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENT INNER PART ERAGON BIPOLAR WAS CHECKED IN THE RESPONSIBLE DEPARTMENT. ONE OF THE TWO INDUSTRY PARTS HAS BROKEN OFF AT THE BOTTOM OF THE INTERLOCKING. THE 83930031 INNER PART ERAGON BIPOLAR FROM BATCH 1376078 WAS BOOKED INTO STOCK ON (B)(6)2018 AND (B)(6) 2018. WITH THE CORRESPONDING PRODUCTION ORDER 1376078 A TOTAL OF 23 PIECES OF THE INNER PART ERAGON BIPOLAR WERE PRODUCED. ON (B)(6) 2018, 3 INNER PART ERAGON BIPOLAR WERE DELIVERED TO THE CUSTOMER FROM BATCH 1376078. THE INNER PART ERAGON BIPOLAR IS IN THE SALES PROGRAM OF RICHARD WOLF SINCE (B)(6) 2008. THE DATABASE OF COMPLAINTS WAS EXAMINED IN THE PERIOD (B)(6) 2017 TO (B)(6) 2020. DURING THIS PERIOD, 967 PIECES OF THE 83930031 INNER PART ERAGON BIPOLAR WERE SOLD. DURING THE PERIOD UNDER REVIEW THERE WAS A COMPARABLE COMPLAINT OF THE INNER PART ERAGON BIPOLAR. THE INTENDED USE OF THE INNER PART ERAGON BIPOLAR UNDER ENDOSCOPIC VIEW WITH BIPOLAR HF CURRENT IS AS FOLLOWS: GRIPPING, MANIPULATION, CUTTING. DISSECTION OF SOFT TISSUE AREAS/ORGANS. COAGULATION, HEMOSTASIS, TISSUE SEPARATION. REMOVAL OF TISSUE SAMPLES. IN THE GA-B 241 / DE INSTRUCTIONS FOR USE, EXPLICIT REFERENCE IS MADE TO THE LIMITED STABILITY OF THE PRODUCT. TOO MUCH FORCE MAY LEAD TO BREAKAGE OR DAMAGE TO THE PRODUCTS. THEREFORE, ONLY SMALL, SOFT TISSUE AREAS/ORGANS MAY BE GRIPPED AND REMOVED WITH THE PRODUCTS. CHAPTER 8 OF THE INSTRUCTIONS FOR USE DESCRIBES VARIOUS CHECKS AND FUNCTION TESTS WHICH THE USER MUST CARRY OUT IN ORDER TO DETECT POSSIBLE DAMAGE TO THE PRODUCT AT AN EARLY STAGE AND TO BE ABLE TO ACT ACCORDINGLY. POSSIBLE HAZARDS HAVE BEEN CONSIDERED IN THE RISK ASSESSMENT B1-2 R03 WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE AND EVALUATED WITH AN ACCEPTABLE RISK. THIS EVALUATION IS STILL VALID EVEN UNDER CONSIDERATION OF THE CURRENT CASE. DUE TO THE DEFECTS / DAMAGE TO THE INNER PART, WE ASSUME MECHANICAL OVERLOADING. THERE ARE NO SIGNS OF A PRODUCTION OR MANUFACTURING DEFECT. RICHARD WOLF (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(4) RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2020 , A PART OF THE INSERT OF ERAGON BIPOLAR FORCEP (83930031) BROKE OFF DURING AN OPERATION IN THE GYNAECOLOGICAL HOSPITAL ON THE ELBE. THE BROKEN PART WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670274 ERAGON BIPOLAR GRASP. FORCEPS INSERT Ø 5.5MM HET RICHARD WOLF GMBH 83930031 1376078 04055207026526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention