BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC TUBING, 6.5MM, WITH LURE CONNECTOR

    MDR report key: 12797612 · Received November 11, 2021

    Report

    Report Number
    1721194-2021-00082
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 28, 2021
    Report Date
    February 28, 2022
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    FCZ
    UDI-DI
    10614559104590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO LOT OR BATCH NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 2/28/2022. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON ENDO SURGERY FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE 2390J TUNING WAS RECEIVED WITH NO APPARENT DAMAGE. THE TUBING WAS SECURED CORRECTLY TO A TEST 2550J (LOT #20024) FILTER TO TEST THE TUBING AND NO LEAK WAS DETECTED WITHIN TUBING AND CONNECTING JOINTS. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, AIR LEAK OCCURRED FROM BETWEEN TROCAR AND THE TIP OF THE EVACUATION TUBE. THE ISSUE OCCURRED 1 HOUR AFTER THE OPERATION WAS STARTED. THE DEVICE WAS USED ON THE LAPAROSCOPIC MODE. THE SURGEON COMMENTED THAT THE SUCTION SEEMS TO BE NOT STOPPED. THE TROCAR WAS LOOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690419 LAPAROSCOPIC TUBING, 6.5MM, WITH LURE CONNECTOR MEGADYNE¿ LAPAROSCOPIC TUBING FCZ MEGADYNE MEDICAL PRODUCTS, INC. 2390J 10614559104590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown