BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII® BALLOON BLUNT TIP SYSTEM

    MDR report key: 21643777 · Received March 19, 2025

    Report

    Report Number
    2027111-2025-00427
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 27, 2025
    Report Date
    July 11, 2025
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915116453
    PMA / PMN Number
    K060629
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 COMPLAINANT¿S EXPERIENCE OF A HOLE IN THE PACKAGING. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS POSSIBLE THAT THE HOLE IN THE PACKAGING WAS CAUSED BY IMPROPER HANDLING OF THE UNIT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATION WAS IDENTIFIED.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT: UPON RECEIVING THE GOODS, THE CUSTOMER NOTICED DAMAGE ON THE PRINTED SIDE OF THE STERILIZATION POUCH AND THEREFORE RETURNED IT TO US. PLEASE FIND THE ATTACHED PHOTOS FOR YOUR REFERENCE. THE CUSTOMER DID NOT USE THE PRODUCT DURING SURGERY AND DIRECTLY REQUESTED US TO RETRIEVE IT. WE HAVE REPLACED IT WITH A NEW UNIT FOR THE CUSTOMER. TYPE OF INTERVENTION: THE CUSTOMER DID NOT USE THE PRODUCT DURING SURGERY AND DIRECTLY REQUESTED US TO RETRIEVE IT. WE HAVE REPLACED IT WITH A NEW UNIT FOR THE CUSTOMER. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT: UPON RECEIVING THE GOODS, THE CUSTOMER NOTICED DAMAGE ON THE PRINTED SIDE OF THE STERILIZATION POUCH AND THEREFORE RETURNED IT TO US. PLEASE FIND THE ATTACHED PHOTOS FOR YOUR REFERENCE. THE CUSTOMER DID NOT USE THE PRODUCT DURING SURGERY AND DIRECTLY REQUESTED US TO RETRIEVE IT. WE HAVE REPLACED IT WITH A NEW UNIT FOR THE CUSTOMER. TYPE OF INTERVENTION: THE CUSTOMER DID NOT USE THE PRODUCT DURING SURGERY AND DIRECTLY REQUESTED US TO RETRIEVE IT. WE HAVE REPLACED IT WITH A NEW UNIT FOR THE CUSTOMER. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561212 KII® BALLOON BLUNT TIP SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES C0R47 1536633 00607915116453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown