BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL ECOCHOICE REGRIND LIGHT HANDLE, STERILE

    MDR report key: 16140202 · Received January 11, 2023

    Report

    Report Number
    1836161-2023-00002
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 8, 2022
    Report Date
    December 12, 2022
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR, INDICATING THAT PRODUCT WAS FOUND WITH SEAL ISSUES. THE DISTRIBUTOR PROVIDED SAMPLES OF THE CONCERNED PRODUCT, WHICH WERE EVALUATED. THE POUCHES HAD AN INCORRECT SETUP ON THE MANUFACTURING LINE, AS THE DISTANCE BETWEEN THE POCKET AND SEALED ENDS IS SUPPOSED TO BE EQUAL, BUT IT WAS NOT FOR THE PROVIDED SAMPLES. THE ROOT CAUSE IS A SETUP ERROR ON THE MANUFACTURING LINE. PRODUCTION PERSONNEL WERE RETRAINED ON MACHINE SETUP AND FIRST INSPECTIONS. WE WILL CONTINUE TO MONITOR THE SITUATION FOR ANY ADDITIONAL RELEVANT INFORMATION. THIS REPORT CAN BE CONSIDERED FINAL, HOWEVER IF WE DISCOVER ANY ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A LIGHT HANDLE WAS DISCOVERED WITH A SEALING ISSUE. THE ITEM WAS NOT IN USE. NO INJURY/DEATH WAS REPORTED. THE ISSUE WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS C-1182591.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A LIGHT HANDLE WAS DISCOVERED WITH A SEALING ISSUE. THE ITEM WAS NOT IN USE. NO INJURY/DEATH WAS REPORTED. THE ISSUE WAS FILED UNDER OUR COMPLAINT HANDLING SYSTEM FOR NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259620 CARDINAL ECOCHOICE REGRIND LIGHT HANDLE, STERILE LIGHT HANDLE FTA ASPEN SURGICAL PRODUCTS, CALEDONIA ECH-01 292991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown