BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTR73, 12X100 KII OPT ZTHR 6/BX

    MDR report key: 18250378 · Received December 1, 2023

    Report

    Report Number
    2027111-2023-00790
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    October 6, 2023
    Report Date
    March 20, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    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.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). 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: OCTOBER 6, 2023. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. ) WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH - CTR73 LOT #1495004 (2 EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (INCOMING INSPECTION).

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT #2023-003419 - HAIRLIKE OBJECT IN POUCH - CTR73 LOT #1495004 ((B)(4) EA). [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: OCTOBER 6,2023 PLEASE REFER TO THE FILE. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH - CTR73 LOT #1495004 ((B)(4) EA) PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451425 CTR73, 12X100 KII OPT ZTHR 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CTR73 1495004 00607915123680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown