BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERAGON MODULAR

    MDR report key: 16005306 · Received December 19, 2022

    Report

    Report Number
    9611102-2022-00060
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    October 7, 2022
    Report Date
    December 19, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCJ
    UDI-DI
    04055207026625
    PMA / PMN Number
    K935270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE 83930074 HANDLE PISTOL SHAPED MONO HAS BEEN IN THE PROGRAMME SINCE 05/04/2011. THE HANDLE WITH THE BATCH NUMBER: 1174853 WAS BOOKED ON 07/03/2012 WITH A TOTAL QUANTITY OF 180 PIECES ON THE NEW GOODS STOCK. ACCORDING TO THE PRODUCTION RECORD, NO INDICATIONS OF PRODUCT OR PRODUCTION DEFECTS ARE APPARENT. SO FAR, NO FURTHER COMPLAINT IS KNOWN FOR THE BATCH: 1174853. THE COMPLAINED FORCEPS SYSTEM, CONSISTING OF THE FOLLOWING COMPONENTS, WAS RETURNED IN ITS ORIGINAL CONDITION, INCLUDING THE TISSUE CUT OUT, AND WAS INSPECTED IN THE TECHNICAL DEPARTMENT: 83930074 HANDLE PISTOL SHAPED MONO, LOT: 1174853, 8393933 SHAFT TUBE INSULATED Ø 5MM SL 330MM, LOT: 1513314, 8393181 GRIPPER INNER PART Ø 5MM, LOT: 1243262. NO OBVIOUS DAMAGE TO THE FORCEPS WAS IDENTIFIED. HOWEVER, THE LATCH LEVER, WHICH GRIPS INTO THE SERRATIONS OF THE MOVABLE HANDLE LEG, SHOWED INWARD BENDING, RESULTING IN INCREASED TENSION WITHIN THE LATCH MECHANISM. FURTHERMORE, THE TWO HANDLE LEGS WERE PRESSED TOGETHER AS FAR AS THEY WOULD GO DURING GRIPPING OF THE TISSUE, WHICH GENERATES ADDITIONAL HIGH TENSION. THE STRONG COMPRESSION LEADS TO A SIGNIFICANT AMOUNT OF FRICTION IN THE LATCHING UNIT, MAKING IT CORRESPONDINGLY MORE DIFFICULT TO RELEASE THE HANDLE AGAIN. HOWEVER, THIS EFFECT IS ALWAYS THE CASE WITH SUCH A LATCHING MECHANISM AND DOES NOT REPRESENT A DEFECT. IN GENERAL, HOWEVER, SUCH A HIGH FORCE APPLICATION IS NOT NECESSARY FOR GRIPPING TISSUE. IN SUMMARY, IT CAN BE SAID THAT THE ERROR PATTERN COULD BE REPRODUCED AND TRACED BACK TO THE ABOVE-MENTIONED FINDINGS. ON THE ONE HAND, THE BENT LATCH LEVER LED TO A PRELOAD AND, ON THE OTHER HAND, THIS PRELOAD WAS ADDITIONALLY INCREASED BY THE STRONG COMPRESSION OF THE HANDLE LEGS. THE COMPLAINTS DATABASE WAS EVALUATED IN THE PERIOD 01/01/2019 - 10/10/2022 FOR THE TYPE 83930074 HANDGRIP PISTOL MONO. DURING THIS PERIOD, A TOTAL OF (B)(4) HANDLES WERE SOLD, WHILE AT THE SAME TIME (B)(4) COMPLAINTS WERE NOTED. ONE OF THESE CASES HAS A SIMILAR DEFECT PATTERN AND WAS REPORTED TO THE BFARM IN 2020, CONCERNING THE SAME CUSTOMER AS IN THIS CASE. FOR PROPER HANDLING, THE FOLLOWING APPLICATION NOTES CAN BE FOUND IN THE ASSOCIATED INSTRUCTIONS FOR USE GA-S027 / EN / 2019-11 V10.0 / PK19-9850 /: 5 INTENDED USE. THE PRODUCTS ARE USED FOR ENDOSCOPICALLY CONTROLLED MANIPULATION AND DISSECTION OF SOFT TISSUE SECTIONS AND ORGANS, FOR GRASPING SUTURE MATERIAL AND NEEDLES, AS WELL AS FOR COAGULATION AND HEMOSTASIS. USE ON THE CENTRAL CIRCULATORY OR NERVOUS SYSTEM IS EXCLUDED. 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. 10.5 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. NOTE: INCREASING THE PRESSURE FORCE ON THE MOVABLE HANDLE ARM (3.2) REDUCES THE ROTATABILITY OF THE ROTATABLE WHEEL (2.2). 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. 11.3 FUNCTION CHECK. 1. CHECK THE OPENING AND CLOSING OF THE JAW SECTIONS (1.1). 2. CHECK THE ROTATABILITY OF THE JAW SECTION (1.1). POTENTIAL HAZARDS WERE CONSIDERED IN RISK ASSESSMENT B1-211, RV00 (REUSABLE RIGID ENERGETIC TONGS AND SCISSORS, ERAGON IIA IIB) WITH THE APPROPRIATE EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE, AND WERE ASSIGNED AN ACCEPTABLE RISK RATING. THIS ASSESSMENT IS STILL VALID EVEN CONSIDERING THE CURRENT CASE. IN CONCLUSION, IT CAN BE STATED THAT THE PRE-DAMAGE FOUND IN THE SENSE OF THE BENDING AT THE LATCH PLATE AND THE EXCESSIVE FORCE APPLIED WHEN GRIPPING THE TISSUE MEANT THAT THE FORCEPS COULD NO LONGER BE OPENED. THESE ERRORS COULD HAVE BEEN PREVENTED IF THE INSTRUCTIONS FOR USE HAD BEEN FOLLOWED. THE EVALUATION OF THE PRODUCTION LOGS AND THE COMPLAINTS DOES NOT REVEAL ANY ABNORMALITIES, SO THAT NO MEASURES ARE CONSIDERED NECESSARY AT THE PRESENT TIME.

    Description of Event or Problem · 0

    RICHARD WOLF GMBH REFERENCE: (B)(4). RICHARD WOLF GMBH IN (B)(4) (MANUFACTURER) WAS INFORMED ABOUT THE FOLLOWING: DESCRIPTION OF INCIDENT/CLAIM: THE RESPECTIVE 5MM GRASPING FORCEPS WAS APPLICATED DURING A THORASCOPICAL RESECTION. AFTER GRASPING OF LUNGS TISSUE WITH ACTIVATED LOCK THE LOCK COULD NOT BE DEACTIVATED AGAIN. AS A CONSEQUENCE THE TISSUE IN THE JAWS HAD TO BE CUT OUT, SO THE FORCEPS COULD RECOVERED AGAIN. THE TREATMENT COULD BE COMPLETED WITHOUT ANY SIGNIFICANT DELAY. THE PATIENT'S CONSEQUENCE WAS DESCRIBED AS "GOOD". DUE TO THE PATIENT INJURY AND A POTENTIAL SERIOUS INCIDENT IF THE CASE WOULD REOCCUR, THE CASE IS DETERMINED AS REPORTABLE. THIS CASE WAS REPORTED BY THE USER TO THE GERMAN AUTHORITIES. RWGMBH MDR AWARENESS DATE: 10-OCT--2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2589211 ERAGON MODULAR HANDLE PISTOL SHAPED MONO GCJ RICHARD WOLF GMBH 83930074 1174853 04055207026625

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8393181 GRIPPER INNER PART Ø 5MM| 8393933 SHAFT TUBE INSULATED Ø 5MM SL 330MM