BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERAGON

    MDR report key: 15455463 · Received September 20, 2022

    Report

    Report Number
    9611102-2022-00045
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 22, 2022
    Report Date
    January 24, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCJ
    UDI-DI
    04055207015810
    PMA / PMN Number
    K935270
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF THE MANUFACTURER RICHARD WOLF GMBH. RICHARD WOLF GMBH HAS ASKED RICHARD WOLF FRANCE TO CONTACT THE USER FOR MORE DETAILS. RICHARD WOLF GMBH HAS REQUESTED AN AFFECTED FORCEPS FOR INVESTIGATION. ACCORDING TO THE USER FACILITY, IT IS A GENERAL PROBLEM WITH THE FORCEPS, THEY CANNOT PROVIDE ANY DEVICE FOR INVESTIGATION. RW GMBH CONSIDERS THIS MATTER OPEN. RW GMBH TRIES TO COLLECT ONE DEVICE IN QUESTION TO BE ABLE TO EVALUATE THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH NEW INFORMATION ABOUT THIS MDR. NEW INFORMATION: B4, B5, D9, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), AND H10. RICHARD WOLF FRANCE WAS COMMISSIONED TO OBTAIN ADDITIONAL INFORMATION OR A SAMPLE PART. THE EFFORTS WERE UNSUCCESSFUL. WHEN REVIEWING THE COMPLAINT RECORDS AT RICHARD WOLF GMBH, NO COMPARABLE CASES / MATCHES WERE FOUND. AS NO LOT NUMBER WAS PROVIDED, NO CONCLUSIONS COULD BE DRAWN WITH REGARD TO THE DATE OF MANUFACTURE. IN THE CORRESPONDING RISK ANALYSIS B1-2 REV.05, MANUFACTURING-RELATED, HANDLING-RELATED AND DESIGN-RELATED HAZARDS WITH REGARD TO A FUNCTIONAL IMPAIRMENT AS WELL AS RISKS DUE TO AN UNSERVICEABLE PRODUCT WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE WERE CONSIDERED AND ASSESSED WITH AN ACCEPTABLE RISK. AS NO NEW RISKS HAVE EMERGED FROM THE INVESTIGATION OF THE CURRENT COMPLAINT CASE, THE RISK ASSESSMENT REMAINS VALID IN VIEW OF THE FACTS DESCRIBED. THE USER IS INFORMED IN THE RELATED INSTRUCTIONS FOR USE GA-S027 / EN / 2019-11 V10.0 / PK19-9850 IN CHAPTERS 10 AND 11 TO CHECK THE INSTRUMENT FOR POSSIBLE DAMAGE BEFORE AND AFTER USE. IN ADDITION, THE USER IS INFORMED THAT IMPROPER USE MAY RESULT IN DAMAGE TO THE INSTRUMENT: 10 USE WARNING THE PRODUCTS HAVE ONLY LIMITED STRENGTH! EXCESSIVE FORCE WILL CAUSE DAMAGE, IMPAIR THE FUNCTION AND THEREFORE ENDANGER THE PATIENT. - IMMEDIATELY BEFORE AND AFTER USE, CHECK THE PRODUCTS FOR DAMAGE, LOOSE PARTS AND COMPLETENESS. MAKE SURE THAT NO MISSING INSTRUMENT PARTS REMAIN IN THE PATIENT. - DO NOT USE PRODUCTS WHICH ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. 10.1 PREPARATION 1. CHECK ASSEMBLY: SECTION 10.2 ASSEMBLY 2. PERFORM A VISUAL CHECK: SECTION 11.2 VISUAL CHECKS. 10.5 GENERAL NOTES AND INSTRUCTIONS FOR USE WARNING DANGER OF INJURY. WHEN INSERTING AND RETRACTING INSTRUMENTS WITH THE JAW SECTION OPEN. UNINTENTIONAL TISSUE DAMAGE, DAMAGE TO THE DISTAL END OF THE TROCAR SLEEVE / ENDOSCOPE, AND TO THE JAW SECTION IS POSSIBLE. ONLY INSERT AND RETRACT INSTRUMENTS WITH THE JAW SECTION CLOSED AND UNDER VISUAL CONTROL. 11 CHECKS WARNING INJURIES BY DAMAGED OR INCOMPLETE PRODUCTS! INJURIES OF THE PATIENT, USER AND OTHERS ARE POSSIBLE. - DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS. - RUN THROUGH THE CHECKS BEFORE AND AFTER EACH USE. BASED ON THE INFORMATION AVAILABLE TO US, NO GENERAL PRODUCT OR DESIGN PROBLEM CAN BE IDENTIFIED. FROM A MANUFACTURING OR DESIGN POINT OF VIEW, NO SYSTEMATIC DEFICIENCIES COULD BE IDENTIFIED AT THIS POINT IN TIME, SO THAT NO MEASURES WERE DEEMED NECESSARY.

    Description of Event or Problem · 0

    RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). USER REPORT MV-2002-00463 IN FRANCE. THE USER HAS REPORTED THE FOLLOWING: GRIPPING FORCEPS TOO TRAUMATIC FOR THE SMALL INTESTINE AND DIGESTIVE TRACT REPEATED WOUNDS, REQUIRING MODIFICATION OF THE PROCEDURE, SUTURES ETC... CLINICAL CONSEQUENCE: PERITONITIS, RECOVERY, MAJOR RISK. RWGMBH AWARENESS DATE, 22-AUG-2022.

    Description of Event or Problem · 0

    RICHARD WOLF GMBH REFERENCE COMPLAINT (B)(4) (FU1 MDR / NO INFORMATION - DEVICE NOT RETURNED). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THAT DEVICE EVALUATION IS NOT AVAILABLE DUE TO DEVICE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661977 ERAGON GRASP. FORCEPS INSERT Ø 5MM GCJ RICHARD WOLF GMBH 8393184 04055207015810

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other