BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERAGON BIPOLAR

    MDR report key: 10397484 · Received August 12, 2020

    Report

    Report Number
    9611102-2020-00018
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 7, 2020
    Report Date
    August 6, 2020
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HET
    UDI-DI
    04055207026526
    PMA / PMN Number
    K033177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENT 83930031 INNER PART ERAGON BIPOLAR Ø 5,5MM FROM BATCH 1425567 HAS BEEN CHECKED IN THE RESPONSIBLE DEPARTMENT. ONE OF THE TWO INDUSTRY PARTS HAS BROKEN OFF AT THE BOTTOM OF THE INTERLOCKING. FURTHERMORE A HARDNESS TEST WAS CARRIED OUT, WHICH IS OK. THE CAUSE IS DUE TO OVERLOAD OF THE 83930031 INNER PART ERAGON BIPOLAR Ø 5,5MM. THE 83930031 INNER PART ERAGON BIPOLAR Ø 5,5MM FROM BATCH 1425567 WAS BOOKED INTO STOCK ON 29.08.2019. WITH THE CORRESPONDING PRODUCTION ORDER 1425567, A TOTAL OF (B)(4) PIECES OF THE 83930031 INNER PART ERAGON BIPOLAR Ø 5,5MM WERE PRODUCED. TO THE CUSTOMER ON 16.09.19 3 PIECES OF INTERNAL PARTS 83930031 INNER PART ERAGON BIPOLAR Ø 5,5MM FROM BATCH 1425567 WERE DELIVERED TO THE CUSTOMER. THE 83930031 INNER PART ERAGON BIPOLAR Ø 5,5MM IS IN THE SALES PROGRAM OF RICHARD WOLF SINCE 09.07.2008. THE DATABASE OF COMPLAINTS WAS EXAMINED IN THE PERIOD 01.01.2017 TO 21.07.2020. DURING THIS PERIOD, (B)(4) PIECES OF THE 83930031 INNER PART ERAGON BIPOLAR Ø 5,5MM WERE SOLD. IN THE PERIOD UNDER REVIEW THERE WERE TWO COMPARABLE COMPLAINTS OF THE 83930031 INNER PART ERAGON BIPOLAR Ø 5,5MM. 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) (RW(B)(4)) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RW(B)(4) RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION(RWMIC) IS SUBMITTING THIS REPORT ON BEHALF OF RWGMBH.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY, DURING THE OPERATION ON (B)(6) 2020, AGAIN A PART OF THE BRANCH OF A 83930031 GRIPPING PLIERS-INNER PART Ø 5,5MM BROKE OFF DURING AN OPERATION IN THE GYNAECOLOGICAL HOSPITAL ON THE ELBE. THE BROKEN OFF PART WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862813 ERAGON BIPOLAR GRASP. FORCEPS INSERT HET RICHARD WOLF GMBH 83930031 1425567 04055207026526

    Patients

    Seq Age Sex Outcome Treatment
    1