BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 16098615 · Received January 4, 2023

    Report

    Report Number
    9611102-2023-00001
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 6, 2022
    Report Date
    March 2, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HIF
    PMA / PMN Number
    K000180
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS RECEIVED BY RICHARD WOLF GMBH FOR INVESTIGATION ON 12/19/2022. (B)(4). THE CUSTOMER HAS RECEIVED (B)(4) PIECES FROM THIS BATCH. IN THE COMPLAINT DATABASE, THERE IS NO FURTHER COMPLAINTS FROM THE BATCH 32086110 BETWEEN 01-01-2019 AND 12-06-2022. ACCORDING TO THE END USER, THEY HAVE MORE PIECES FROM DIFFERENT BATCHES, BUT THEY HAVE NOT DISCOVERED THE REPORTED ISSUE AT THOSE PIECES. RW GMBH HAS CHECKED 9 PIECES FROM REMAINED SAMPLES OF THE BATCH. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE REPORTED DEVICE WAS FORWARDED TO THE SUPPLIER FOR FURTHER INVESTIGATION. THE INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE TEM TUBE SET 4170801 FROM THE BATCH 32086110 WAS INVESTIGATED BY THE SUPPLIER. THE REPORTED ISSUE WAS CONFIRMED. THE TUBE WITH RED CONNECTORS WAS ASSEMBLED INCORRECTLY INTO THE BUNDLE OF TUBES. THE ROOT CAUSE IS A PRODUCTION FAILURE. THE TEM TUBE SET 4170801 FROM THE BATCH 32086110 WAS MANUFACTURED ON 22/FEB/2020. THE BATCH CONSISTED OF 777 SETS. NO ISSUE WAS IDENTIFIED DURING PRODUCTION, THE RETAIN SAMPLES AT THE SIDE OF THE SUPPLIER AND AT RICHARD WOLF GMBH WERE REVIEWED, BUT THE REPORTED ISSUE COULD NOT BE CONFIRMED AT THOSE SAMPLES. NO FURTHER COMPLAINTS WERE RECEIVED REGARDING THE REPORTED ISSUE. THE IFU GA-AS 001-USA / EN / 2014-01 V7.0 / ECO 2013-0434 CONTAINS SAFETY NOTES OF CHECK THE COMPLETE DEVICE SYSTEM INCLUDING THE TEM TUBE SET BEFORE USE IN SECTION 3.1 INSTALLATION OF THE TEM COMBINATION SYSTEM AND IN SECTION 5 CHECKS. THE USER IS ADVISED TO HAVE A BACK-UP DEVICE AVAILABLE IN CASE OF A DEVICE FAILURE IN SECTION 1.2.2 TEM PUMP. THE SUBJECT ISSUE OF DELAY IN THE PROCEDURE IS PRESENT IN THE RISK MANAGEMENT FILE P08FO015 E1-1: LAPAROSCOPIC INSUFFLATORS (INCL. TEM) WITH ACCESSORIES, REV. V00. THE OVERALL PROBABILITY OF OCCURRENCE FOR THIS ISSUE REMAINS AT PREVIOUSLY DEFINED LEVELS AND OVERALL RISK OF THE DEVICE REMAINS IN THE ACCEPTABLE CATEGORY.

    Description of Event or Problem · 0

    RWGMBH REFERENCE COMPLAINT NO. (B)(4). THE USER REPORTED THE FOLLOWING: "THERE WERE SEVERAL ISSUES: 1. THE TEM IRRIGATION CANNULA HAD A VALVE INCORRECTLY ASSEMBLED BY THE EXTERNAL REPROCESSING COMPANY, THEREFORE THE IRRIGATION CANNULA DID NOT WORK AND A WORKING REPLACEMENT WAS TAKEN FROM THE 2ND [SIEB]. THIS PROBLEM WAS RESOLVED WITH DELAY. 2. WHEN CONNECTING THE TEM TUBING SET, THE RED CONNECTOR OF THE SUCTION TUBING "D" COULD NOT BE CONNECTED TO THE INSTRUMENT, BECAUSE THIS TUBING IS OBVIOUSLY REVERSED IN THE BUNDLE OF THE TUBING SET (LARGE RED AND SMALL RED CONNECTOR EACH REVERSED ON WRONG SIDE OF THE TUBING SET)." ACCORDING TO THE USER, THERE WAS DELAY OF ONE HOUR AND THE PLANNED PROCEDURE COULD NOT BE COMPLETED. THE USER NEEDED TO SWITCH TO ANOTHER SURGICAL METHOD WITH POORER IMAGING, AS A RESULT THAT THE TUMOR COULD NOT BE SAFELY REMOVED COMPLETELY AND FROM THE HEALTHY TISSUE. IN FOLLOW-UP CARE, DETERIORATION OF THE PROGNOSIS OR FURTHER SURGERY MUST BE EXPECTED. RWGMBH MDR AWARENESS DATE: (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178546 NA TEM TUBE SET HIF RICHARD WOLF GMBH 4170801 32086110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other