BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTR73, 12X100 KII OPT ZTHR 6/BX

    MDR report key: 15996728 · Received December 16, 2022

    Report

    Report Number
    2027111-2022-00860
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    October 17, 2022
    Report Date
    February 1, 2023
    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
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT HAS BEEN RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF A CRACKED CANNULA TIP. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE REPORTED EVENT WAS DUE TO EXCESS FORCE EXERTED ON THE CANNULA DUE TO PORT PLACEMENT BETWEEN THE RIBS, THE CANNULA BEING MORE SUSCEPTIBLE TO FRACTURE, OR A COMBINATION OF BOTH. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: MIVS MV REPLACEMENT. EVENT DESCRIPTION: MIVS-MITRAL VALVE REPLACEMENT. TROCAR NOTED TO BE CRACKED AT END WHEN REMOVED FROM PATIENT. NO MISSING PIECES NOTED. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 05DEC2022 VIA EMAIL FROM DISTRIBUTOR: THERE WAS ONLY ONE CTR73 UNIT REPORTED TO [DISTRIBUTOR] IN THIS INCIDENT. PATIENT STATUS: NO HARM REPORTED TO THE PATIENT.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: MIVS MV REPLACEMENT. EVENT DESCRIPTION: MIVS-MITRAL VALVE REPLACEMENT. TROCAR NOTED TO BE CRACKED AT END WHEN REMOVED FROM PATIENT. NO MISSING PIECES NOTED. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 05DEC2022 VIA EMAIL FROM DISTRIBUTOR: THERE WAS ONLY ONE CTR73 UNIT REPORTED TO [DISTRIBUTOR] IN THIS INCIDENT. PATIENT STATUS: NO HARM REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570780 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