BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBIENT SUPER TURBOVAC 90 IFS

    MDR report key: 10280316 · Received July 15, 2020

    Report

    Report Number
    3006524618-2020-00494
    Event Type
    Injury
    Date Received
    July 15, 2020
    Report Date
    September 7, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470000016
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REPORTED, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE PRODUCT AND REPORTED INCIDENT WAS ESTABLISHED. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE PERFORMED. THEREFORE, NO FURTHER INTERPRETATION OF THE ATTACHED IMAGES IS REQUIRED, AND NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. A REVIEW OF THE PICTURED PROVIDED IN THE ARTICLE SHOWED THE PATIENT WAS BURNED. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE COMPLETED SINCE A LOT NUMBER WAS NOT AVAILABLE. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND CONTAINS WARNINGS AND PRECAUTIONARY MEASURES RELATED TO PROPER USE OF THE DEVICE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A VISUAL INSPECTION AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED AS THE ARTICLE PROVIDED PICTURES OF THE PATIENT BURNS. POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO THE FAILURE REPORTED INCLUDE, BUT ARE NOT LIMITED TO: (1) PRE-WARMED SALINE WAS USED (2) THE SET POINT WAS LOWER THAN THE DEFAULT SET POINT (3) INADEQUATE FLOW AND CIRCULATION OF SALINE. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A 2ND DEGREE DERMAL BURN WITH AMBIENT SUPER TURBOVAC AFTER AN ARTHROSCOPIC ACROMIOPLASTY AND ROTATOR CUFF REPAIR. NO FURTHER INFORMATION IS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741510 AMBIENT SUPER TURBOVAC 90 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASHA4250-01 UNKNOWN 00817470000016

    Patients

    Seq Age Sex Outcome Treatment
    1