BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 4131405 · Received October 1, 2014

    Report

    Report Number
    3005075853-2014-06773
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 16, 2014
    Report Date
    June 21, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (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. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE DEVICE WAS NOT USED ON THE PATIENT. THE CASE WAS FINISHED WITH A 5MM BLADELESS XCEL TROCAR W/STABILITY SLEEVE, CAT# B5LT, LOT# L4EN8M.

    Additional Manufacturer Narrative · 1

    (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. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE DEVICE WAS NOT USED ON THE PATIENT. THE CASE WAS FINISHED WITH A 5MM BLADELESS XCEL TROCAR W/STABILITY SLEEVE, CAT# B5LT, LOT# L4EN8M.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS FOUND TO HAVE A BROKEN CANNULA UPON OPENING. IN ORDER TO FINISH CASE, THE DOCTOR HAD TO OPEN ANOTHER TROCAR. THERE WERE NO PATIENT CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS FOUND TO HAVE A BROKEN CANNULA UPON OPENING. IN ORDER TO FINISH CASE, THE DOCTOR HAD TO OPEN ANOTHER TROCAR. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611244 ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA L4F14N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown