BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINVATEC 10K100 ARTHR.TUBE SET

    MDR report key: 10823152 · Received November 11, 2020

    Report

    Report Number
    3007305485-2020-00481
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    October 22, 2020
    Report Date
    December 16, 2020
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    HRX
    PMA / PMN Number
    K033573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED IN THE ORIGINAL CONMED SHIPPING BAG. VISUAL EXAMINATION OF RETURNED ITEM CONFIRMED DEBRIS AT THE TUBE SET. PER STERILE PACKAGE PARTICULATE & SEAL WIDTH CHART, T30-003-140, REV-AC AND SI-000-092, REV-AL FOREIGN SUBSTANCE IS NOT ACCEPTABLE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE HAVE BEEN 2 COMPLAINTS FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE THE USER IS ADVISED THAT TUBING SETS SHOULD ONLY BE USED IF THE ORIGINAL PACKAGING AND LABELING ARE INTACT. A DETERMINATION FOR FURTHER INVESTIGATION HAS BEEN INITIATED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    SECONDARY FDA PRODUCT CODE IS GCJ. THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE, 10K100, WAS BEING USED DURING A CHOLELITHOTOMY ON (B)(6) 2020 WHEN IT WAS REPORTED THAT "THE HOSPITAL FOUND THE MULTIPLE WHITE DEBRIS DURING THE SURGERY AND THEY SAID THAT THEY REMOVED THE VISIBLE WHITE DEBRIS WITH A FORCEP AS MUCH AS THEY CAN." THE PROCEDURE WAS COMPLETED AFTER A 30-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO NOT KNOWING IF ALL DEBRIS WAS REMOVED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290089 LINVATEC 10K100 ARTHR.TUBE SET ARTHROSCOPE HRX CONSOLIDATED MEDICAL EQUIPMENT 202003275

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other