BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCA 9F COMPLETE SET,EO

    MDR report key: 8949270 · Received August 30, 2019

    Report

    Report Number
    1216677-2019-00243
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 14, 2019
    Report Date
    May 7, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    BZD
    PMA / PMN Number
    K911780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE (B)(4). INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION. X-NO SAMPLE RETURNED . X-REVIEW DHR. ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 1/22/2018 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW: DHR-44-2709-233700 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD : SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE ATTACHED 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. ALL SIMILAR REPORTED COMPLAINTS WERE ATTRIBUTED TO USE OF INCOMPATIBLE, NON-COOPERSURGICAL CONNECTORS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE : ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    INTERNAL DIAMETER OF WHITE ADAPTORS NOT FITTING SNUG TO VENT CIRCUITS AS BEFORE. REF (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    INTERNAL DIAMETER OF WHITE ADAPTORS NOT FITTING SNUG TO VENT CIRCUITS AS BEFORE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746116 INCA 9F COMPLETE SET,EO INCA BZD COOPERSURGICAL, INC. 44-2709 233700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other