BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX

    MDR report key: 15544229 · Received October 5, 2022

    Report

    Report Number
    2027111-2022-00761
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 9, 2022
    Report Date
    December 1, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915126773
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT OF THE TISSUE BAG FALLING OFF THE SUPPORTS. BASED ON THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY A DOWNWARD FORCE THAT WAS EXERTED ON THE BAG, RESULTING IN THE TISSUE BAG FALLING OFF THE SUPPORTS. 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: ROBOTIC ASSISTED RADICAL RIGHT NEPHRECTOMY. EVENT DESCRIPTION: THREE COMPLAINT EVENTS OCCURRED DURING THE SAME PROCEDURE: COMPLAINT 1 OF 3: (B)(6) LOT#: 1443786, FIRST INZII USED, COMPLAINT 2 OF 3: (B)(6) LOT#: 1440141, SECOND INZII USED, COMPLAINT 3 OF 3: (B)(6) LOT#: 1451644, THIRD INZII USED. REP WAS NOT PRESENT FOR THE CASE. WHEN THE PHYSICIAN TRIED TO DEPLOY THE BAGS THE PRONGS ADVANCED BUT DID NOT OPEN, THEY STAYED CLOSED TOGETHER. THIS HAPPENED WITH THREE DEVICES. THE END OF THE TUBE WAS OUT OF THE CANNULA AS IT SHOULD BE. THE PRONGS WERE NOT EXPOSED INSIDE THE PATIENT, THEY WERE ALWAYS COVERED BY THE BAG. THE SURGEON IS A VERY EXPERIENCED USER. THE CASE WAS COMPLETED WITH THE FOURTH CD004. THERE WAS NO PATIENT INJURY. NONE OF THE EVENT UNITS ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2022 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER III THE BAG DID NOT UNROLL AND THERE WAS AN ATTEMPT TO UNROLL IT. THE ACTUATOR WAS FULLY ADVANCED AND THE BAG WAS COMPLETELY OUT OF THE TUBE. THE BAG DID SLIP DOWN THE METAL SUPPORTS, ATTEMPTS TO MANIPULATE RESULTED IN THE BAG FALLING OFF THE SUPPORTS. ON ALL 3 BAGS THAT WERE DEFECTIVE. THE 4TH BAG FUNCTIONED NORMALLY. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: THE CASE WAS COMPLETED WITH THE FOURTH DEVICE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: ROBOTIC ASSISTED RADICAL RIGHT NEPHRECTOMY. EVENT DESCRIPTION: THREE COMPLAINT EVENTS OCCURRED DURING THE SAME PROCEDURE: COMPLAINT 1 OF 3: 2022-002460 - CD004 LOT #1443786, FIRST INZII USED. COMPLAINT 2 OF 3: 2022-002461 - CD004 LOT #1440141, SECOND INZII USED. COMPLAINT 3 OF 3: 2022-002462 - CD004 LOT #1451644, THIRD INZII USED. REP WAS NOT PRESENT FOR THE CASE. WHEN THE PHYSICIAN TRIED TO DEPLOY THE BAGS THE PRONGS ADVANCED BUT DID NOT OPEN, THEY STAYED CLOSED TOGETHER. THIS HAPPENED WITH THREE DEVICES. THE END OF THE TUBE WAS OUT OF THE CANNULA AS IT SHOULD BE. THE PRONGS WERE NOT EXPOSED INSIDE THE PATIENT, THEY WERE ALWAYS COVERED BY THE BAG. THE SURGEON IS A VERY EXPERIENCED USER. THE CASE WAS COMPLETED WITH THE FOURTH CD004. THERE WAS NO PATIENT INJURY. NONE OF THE EVENT UNITS ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 03OCT2022 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER III. THE BAG DID NOT UNROLL AND THERE WAS AN ATTEMPT TO UNROLL IT. THE ACTUATOR WAS FULLY ADVANCED AND THE BAG WAS COMPLETELY OUT OF THE TUBE. THE BAG DID SLIP DOWN THE METAL SUPPORTS, ATTEMPTS TO MANIPULATE RESULTED IN THE BAG FALLING OFF THE SUPPORTS. ON ALL 3 BAGS THAT WERE DEFECTIVE. THE 4TH BAG FUNCTIONED NORMALLY. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: THE CASE WAS COMPLETED WITH THE FOURTH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505842 CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX LAPAROSCOPIC, GENERAL PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD004 1443786 00607915126773

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown C0R37