BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTR73, 12X100 KII OPT ZTHR 6/BX

    MDR report key: 16018655 · Received December 20, 2022

    Report

    Report Number
    2027111-2022-00798
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    September 6, 2022
    Report Date
    December 20, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915123680
    PMA / PMN Number
    K060096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: NA. EVENT DESCRIPTION: [FACILITY] INCOMING INSPECTION PO#: 23036. THIS IS A COMPLAINT FROM [FACILITY] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: ON (B)(6) 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. FOREIGN OBJECT INSIDE PRODUCT - CTR73 LOT#: 1455625 (1 EA.). PRODUCT AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023576 CTR73, 12X100 KII OPT ZTHR 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CTR73 1455625 00607915123680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown