BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GTK14, ALEXIS CES 14CM W KII BALLOON

    MDR report key: 15705397 · Received October 31, 2022

    Report

    Report Number
    2027111-2022-00803
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    September 9, 2022
    Report Date
    December 16, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K211043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE PRESENCE OF HAIR INSIDE THE STERILE UNOPENED POUCH. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, THE HAIR LIKELY ORIGINATED FROM AN OPERATOR DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    THE EVENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO# (B)(4) THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: SEPTEMBER 8,2022. PLEASE REFER TO THE ATTACHMENT FILE. I) WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR THE FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIR-LIKE OBJECT IN POUCH - GTK14 LOT #1464929 (1 EA.) PRODUCT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION) DETAILED DESCRIPTION OF EVENT: [FACILITY] INCOMING INSPECTION PO#(B)(4). THIS IS A COMPLAINT FROM [FACILITY] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: SEPTEMBER 8, 2022. I) WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR THE FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIR-LIKE OBJECT IN POUCH - GTK14 LOT #1464929 (1 EA.). PRODUCT AVAILABLE FOR RETURN. PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458766 GTK14, ALEXIS CES 14CM W KII BALLOON LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES GTK17 1464929

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown