BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    MDR report key: 8710302 · Received June 18, 2019

    Report

    Report Number
    2027111-2019-00482
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    April 26, 2019
    Report Date
    June 18, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915117382
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING WAS UNABLE TO BE PERFORMED AND THE COMPLAINANT¿S EXPERIENCE COULD NOT BE CONFIRMED. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. THIS IS A COMBINED INITIAL AND FOLLOW-UP REPORT IN RESPONSE TO MW5086289.

    Description of Event or Problem · 1

    NAME OF PROCEDURE BEING PERFORMED: NI. DETAILED DESCRIPTION OF EVENT: "WHILE USING THE APPLIED MEDICAL RESOURCES CORP., INZII RETRIEVAL SYSTEM ACCORDING TO THE MFR'S INSTRUCTIONS. IT WAS NOTED THAT THE DEVICE WAS UNABLE TO CINCH CLOSE THE ENDOSCOPIC POUCH. THE GALLBLADDER WAS ABLE TO BE REMOVED WITH THE OPEN POUCH. FDA SAFETY REPORT ID#: (B)(4)." TYPE OF INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY & NO INFORMATION REGARDING THE PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501880 CD001, 10MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD001 1346511 00607915117382

    Patients

    Seq Age Sex Outcome Treatment
    1