BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    MDR report key: 10434896 · Received August 20, 2020

    Report

    Report Number
    2027111-2020-00532
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    August 17, 2020
    Report Date
    October 23, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GJC
    UDI-DI
    00607915117382
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. ENGINEERING OBSERVED THAT A PORTION OF THE TISSUE BAD HAD FRAGMENTED. THE CORD LOOP WAS CUT CLEANLY, WHICH INDICATES THAT IT WAS CUT BY AN INSTRUMENT. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE TISSUE BAG AND CORD LOOP WERE CUT BY AN INSTRUMENT, WHICH CAUSED THE TISSUE BAG TO FRAGMENT. 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: LAP. CHOLECYSTECTOMY. AFTER RETRIEVE THE GALLBLADER, THEY FOUND A PART OF A PLASTIC IN THE PATIENT. EVERYTHING WAS FOUND AND ALL PARTS ARE TOGETHER FOR RETURN THE PRODUCT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17AUG2020: THE CUSTOMER HAS CONFIRMED THAT THE PLASTIC PART IS PART OF THE DEVICE. IT'S A GREEN/BLUE PLASTIC PART. THE CUSTOMER DID NOT GIVE ANY FURTHER DETAILS AS TO ITS SHAPE. PATIENT STATUS: OK. TYPE OF INTERVENTION: RETRIEVAL OF SEPARATED PART.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAP. CHOLECYSTECTOMY. AFTER RETRIEVE THE GALLBLADDER, THEY FOUND A PART OF A PLASTIC IN THE PATIENT. EVERYTHING WAS FOUND AND ALL PARTS ARE TOGETHER FOR RETURN THE PRODUCT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17AUG2020: THE CUSTOMER HAS CONFIRMED THAT THE PLASTIC PART IS PART OF THE DEVICE. IT'S A GREEN/BLUE PLASTIC PART. THE CUSTOMER DID NOT GIVE ANY FURTHER DETAILS AS TO ITS SHAPE. PATIENT STATUS: OK. TYPE OF INTERVENTION: RETRIEVAL OF SEPARATED PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899683 CD001, 10MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GJC APPLIED MEDICAL RESOURCES CD001 1386855 00607915117382

    Patients

    Seq Age Sex Outcome Treatment
    1