BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENICON NATURA

    MDR report key: 9803322 · Received March 6, 2020

    Report

    Report Number
    3002590791-2020-00004
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    October 11, 2018
    Report Date
    March 6, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K991382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION AVAILABLE TO CONDUCT INVESTIGATION. THE ALLEGED DEFICIENCY INDICATES SOME MATERIAL SEPARATION OCCURRED BECAUSE THE "TIP HAS FALLEN OFF". THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO FINDINGS ARE AVAILABLE AND THE CAUSE IS NOT ESTABLISHED. MOREOVER, WE DO NOT KNOW ANY IMPACT OR CONSEQUENCE TO THE PATIENT, ALTHOUGH THE ORIGINAL CALL SUGGESTED A POTENTIAL THAT SOME PART OF THE TIP REMAINED IN THE PATIENT AFTER SURGERY.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES A PREVIOUSLY UNREPORTED SERIOUS INJURY EVENT. ON (B)(6) 2018, THE COMPANY RECEIVED A TELEPHONE CALL STATING THE TIP OF A TROCAR FELL INSIDE A PATIENT. THERE IS SOME POTENTIAL, BASED ON THE INFORMATION PROVIDED, THAT SOME PART OF THE TIP REMAINED IN THE PATIENT FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260940 GENICON NATURA TROCAR GCJ GENICON, INC. 210-005-051 I6466-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other