BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    MDR report key: 12194093 · Received July 19, 2021

    Report

    Report Number
    2027111-2021-00579
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    July 9, 2021
    Report Date
    September 29, 2021
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY DAMAGES OR NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE EVENT DESCRIPTION, IT IS LIKELY THAT THE SUPPORTS WERE COVERED BY THE TISSUE BAG AND THE SUPPORT TIPS APPEARED VISIBLE AS THE TISSUE BAG IS TRANSPARENT. HOWEVER, IN THE ABSENCE OF THE EVENT UNIT, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE BAG FELL OFF THE SUPPORTS. ADDITIONALLY, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE DEVICE JAM WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    TYPE OF PROCEDURE PERFORMED: LAPAROSCOPY. CER 1 OF 5: 2021-001661. CER 2 OF 5: 2021-001662. CER 3 OF 5: 2021-001663. CER 4 OF 5: 2021-001664. CER 5 OF 5: 2021-001665. THE THREAD HAS WRAPPED AROUND THE RETRIEVAL BAG. ONLY THE METAL GUIDE APPEARED WHEN THEY APPLIED THE INZII 10MM ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 04-AUG-2021: THE METAL TIPS WERE EXPOSED INSIDE THE PATIENT'S ABDOMEN, WHEN THEY WANTED TO USE THE CD001. THE BAG REMAINED STUCK INSIDE THE TUBE, THEY DIDN'T MANIPULATE IT INSIDE THE ABDOMEN. THE CD001 WAS REMOVED. THE BAG WAS LATER PULLED OUT WITH A GRASPER, ON THE NURSE'S TABLE. THE SITUATION WAS RESOLVED BY TAKING A NEW DEVICE. PATIENT STATUS: OK. TYPE OF INTERVENTION: CHANGE OF DEVICE.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT IS NOT ANTICIPATED TO RETURN FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    TYPE OF PROCEDURE PERFORMED: LAPAROSCOPY. CER 1 OF 5: (B)(4). CER 2 OF 5: (B)(4). CER 3 OF 5: (B)(4). CER 4 OF 5: (B)(4). CER 5 OF 5: (B)(4). THE THREAD HAS WRAPPED AROUND THE RETRIEVAL BAG. ONLY THE METAL GUIDE APPEARED WHEN THEY APPLIED THE INZII 10MM. PATIENT STATUS: OK. TYPE OF INTERVENTION: NI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090242 CD001, 10MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD001 1410745 00607915117382

    Patients

    Seq Age Sex Outcome Treatment
    1