BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17657156 · Received August 30, 2023

    Report

    Report Number
    2027111-2023-00584
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    July 12, 2023
    Report Date
    November 15, 2023
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    CGJ
    UDI-DI
    00607915126773
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF THE SPECIMEN BAG FALLING OFF THE METAL SUPPORTS. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCTS AND IS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT BASED ON THE EVALUATION OF THE RETURNED UNIT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS EVENT HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS ANTICIPATED TO RETURN TO APPLIED MEDICAL. A FOLLOW-UP REPORT WILL BE PROVIDED FOLLOWING THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: UROLOGY. EVENT DESCRIPTION: [FACILITY] REPORT FROM THE SALES REP. DURING A UROLOGY DA VINCI CASE, CD004 DID NOT MAKE A CLICKING SOUND WHEN PUSHING OUT THE COLLECTION BAG. AFTER THAT, WHEN THE BAG WAS PUSHED INTO THE BODY, THE BAG FELL OFF FROM THE HOLDER PART OF THE SHAFT. THE MISSING PARTS HAVE BEEN COLLECTED. THE CASE WAS COMPLETED WITH THE NEW ONE. THE ADDITIONAL INFORMATION IS AS FOLLOWS; THE METAL SUPPORTS WAS FULLY EXPOSED UPON DEPLOYMENT. THERE WAS NO JAMMING DURING DEPLOYMENT. RATHER, THERE WAS NO RESISTANCE WHEN PUSHING THE HANDLE OUT (NO CLICK-LIKE SOUND WAS HEARD). THE PLUNGER/ACTUATOR PUSH FORWARD ONLY ONCE TOWARDS THE HANDLES. THE DEVICE HAS BEEN SAFELY REMOVED AND RECOVERED. THE WAY TO REMOVE WAS UNKNOWN. IT WAS CONFIRMED THAT THERE WAS ENOUGH ROOM IN THE BODY CAVITY FOR THE BAG TO OPEN. USED ABOUT 5 TIMES PER YEAR. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE BAG WAS FOUND TO BE DETACHED FROM THE DEVICE. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE PATIENT STATUS: NO PATIENT INJURY.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: UROLOGY. EVENT DESCRIPTION: [FACILITY]: REPORT FROM THE SALES REP: DURING A UROLOGY DA VINCI CASE, CD004 DID NOT MAKE A CLICKING SOUND WHEN PUSHING OUT THE COLLECTION BAG. AFTER THAT, WHEN THE BAG WAS PUSHED INTO THE BODY, THE BAG FELL OFF FROM THE HOLDER PART OF THE SHAFT. THE MISSING PARTS HAVE BEEN COLLECTED. THE CASE WAS COMPLETED WITH THE NEW ONE. THE ADDITIONAL INFORMATION IS AS FOLLOWS; THE METAL SUPPORTS WAS FULLY EXPOSED UPON DEPLOYMENT. THERE WAS NO JAMMING DURING DEPLOYMENT. RATHER, THERE WAS NO RESISTANCE WHEN PUSHING THE HANDLE OUT (NO CLICK-LIKE SOUND WAS HEARD). THE PLUNGER/ACTUATOR PUSH FORWARD ONLY ONCE TOWARDS THE HANDLES. THE DEVICE HAS BEEN SAFELY REMOVED AND RECOVERED. THE WAY TO REMOVE WAS UNKNOWN. IT WAS CONFIRMED THAT THERE WAS ENOUGH ROOM IN THE BODY CAVITY FOR THE BAG TO OPEN. USED ABOUT 5 TIMES PER YEAR. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE BAG WAS FOUND TO BE DETACHED FROM THE DEVICE. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389830 CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY CGJ APPLIED MEDICAL RESOURCES CD004 1469852 00607915126773
    906803 CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY CGJ APPLIED MEDICAL RESOURCES CD004 1469852 00607915126773

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown