BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 15660223 · Received October 24, 2022

    Report

    Report Number
    9611102-2022-00056
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    November 22, 2021
    Report Date
    October 24, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    UDI-DI
    04055207048641
    PMA / PMN Number
    K002000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE COURSE OF COMPLAINT PROCESSING, THE CAUSE WAS TRACED BACK TO A USER ERROR AT THE PUMP PRESSURE. A TOO HIGH VACUUM VALUE OP SUCTION CUP/PUMP FROM MANUFACTURER ATMOS WAS USED, THIS IS INDICATED WITH UP TO -910MBAR (-0, 9 BAR VACUUM) VACUUM VALUE. THIS ATMOS PUMP GENERATES A TOO HIGH VACUUM COMPARED TO THE R. WOLF PUMP TYPE 2215001. THE PUMP R. WOLF TYPE 2215001 IS SPECIFIED WITH MAX. -600 MBAR (-0, 6 BAR) VACUUM VALUE. A PRESSURE THAT IS SET TOO HIGH ON THE PUMP DAMAGES THE TUBING (E.G. DEFORMATIONS), LEADS TO LEAKAGE WITHIN THE SUCTION PURGE SYSTEM OR THE PINCH VALVES. THE PRESSURE APPLIED TO THIS SYSTEM SHOULD NOT EXCEED A VALUE OF 500 MMHG (0.66 BAR), SEE INSTRUCTIONS FOR USE GA-B 145 CHAPTER 7.2. A BUCKLED TUBING IS NOT RESTRICTED IN THE SUCTION AND RINSING FUNCTION AND CAN BE REGARDED AS AN OPTICAL DEFECT. THE 4170956 SUCTION-IRRIGATION TUBE SET WITH PIERCING SPIKE HAS BEEN IN THE PROGRAM SINCE (B)(6) 2001. THE BATCH 32245571 WAS PRODUCED ON (B)(6) 2021 AND 567 PAK WAS POSTED TO THE NEW GOODS INVENTORY ON (B)(6) 2021. A TOTAL OF 425 PAKS FROM THE BATCH WERE SHIPPED TO THE DISTRIBUTOR IN CANADA ON (B)(6) 2021. 1 PAK CONTAINS 10 PIECES. THE CERTIFICATE OF QUALITY FROM THE SUPPLIER IS AVAILABLE, IN WHICH HE CONFIRMS THE QUALITY FOR A QUANTITY OF 5670 PIECES OF 4170956 SUCTION-IRRIGATION TUBE SETS WITH THE BATCH 32245571. AN ANALYSIS OF THE COMPLAINTS DATABASE IN THE PERIOD (B)(6) 2019 TO (B)(6) 2022 FOR TYPE 4170956 RESULTED IN A TOTAL OF 21932 DELIVERIES AND 8 COMPLAINTS. 3 OF THEM ARE TO BE CONSIDERED AS SIMILAR CASES, WHICH ALSO DEAL WITH THE ISSUE OF "COLLAPSING TUBES". THESE SIMILAR CASES ARE ALL KNOWN ONLY FROM THIS CUSTOMER / DISTRIBUTOR IN CANADA, FROM DIFFERENT BATCHES. THE INSTRUCTIONS FOR USE OF THE SOURCE (E.G. PUMP) USED IN COMBINATION MUST BE OBSERVED, SEE GA-B145. IN GENERAL, THE USER IS ADVISED, THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE AND AFTER EACH USE. IN ADDITION, IN CHAPTER 7.2, THE USER IS EXPLICITLY INFORMED THAT A PRESSURE THAT IS SET TOO HIGH CAN DAMAGE THE TUBING OR CAN LEAD TO LEAKAGES AND THAT THE PRESSURE SHOULD NOT EXCEED THE VALUE OF 500 MMHG (<= 0.66 BAR). IN THE RELEVANT RISK ANALYSIS F1-2, MANUFACTURING-RELATED, HANDLING-RELATED AND DESIGN-RELATED HAZARDS REGARDING A FUNCTIONAL IMPAIRMENT OR UNUSABLE PRODUCT WERE CONSIDERED AND ASSESSED WITH AN ACCEPTABLE RISK. SINCE NO NEW RISKS HAVE ARISEN FROM THE INVESTIGATION OF THE CURRENT COMPLAINT CASE, THE RISK ASSESSMENT REMAINS VALID IN VIEW OF THE FACTS DESCRIBED. TAKING INTO ACCOUNT ALL THE FINDINGS, NO SYSTEMATIC DEFECTS CAN BE IDENTIFIED EITHER IN TERMS OF FUNCTIONALITY OR FROM A DESIGN AND MANUFACTURING PERSPECTIVE. ACCORDINGLY, NO PRODUCT-RELATED MEASURES ARE CONSIDERED. THE IDENTIFIED DEFECT INDICATES A USER ERROR DUE TO NON-OBSERVANCE OF THE IFU AND A VACUUM VALUE SET TOO HIGH. RW GMBH CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RW GMBH RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) IS SUBMITTING THE REPORT ON BEHALF OF RW GMBH.

    Description of Event or Problem · 0

    RWGMBH REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2021 RICHARD WOLF GMBH (RW GMBH) WAS NOTIFIED BY A CANADIAN DISTRIBUTOR THAT A CUSTOMER'S 4170956 SUCTION-IRRIGATION TUBE SET WITH PIERCING SPIKE APPEARED TO HAVE COLLAPSED RESULTING IN POOR OR NO SUCTION. THE USER HAD TO MANUALLY MANIPULATE THE TUBING SET TO MAINTAIN SUCTION. SINCE, ACCORDING TO THE CUSTOMER, THE APPLICATION COULD BE COMPLETED WITHOUT PATIENT INJURY OR SURGICAL DELAYS, THE DECISION WAS MADE ON (B)(6) 2022, THAT IT WAS NOT REPORTABLE AND THE CASE WAS CLASSIFIED AS A COMPLAINT. THE COMPLAINT WAS CLOSED ON (B)(6) 2022. ON (B)(6) 2022, RW GMBH WAS REQUESTED BY THE CANADIAN AUTHORITY TO SUBMIT A STATEMENT ON THIS CASE, SO THAT COMPLAINT (B)(4) WAS REOPENED AND CLASSIFIED AS A VIGILANCE CASE. RWGMBH MDR AWARENESS DATE:(B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147572 NA SUCT./IRRIG.TUBE SET SPIKE L 3M PVC GEI RICHARD WOLF GMBH 4170956 32245571 04055207048641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown