BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO ENDO5 ML

    MDR report key: 8124500 · Received December 3, 2018

    Report

    Report Number
    3003898360-2018-00973
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    November 8, 2018
    Report Date
    November 12, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K152081
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME INTO THE HOSPITAL WITH ECTOPIC PREGNANCY. THE DOCTOR PERFORMED A LAPAROSCOPIC PROCEDURE. DURING THE PROCEDURE HE NOTICED BLEEDING IN THE ADNEXAL VASCULAR STRUCTURES. HE TYPICALLY USES METAL VASCULAR CLIPS TO CONTROL BLEEDING, BUT NONE WERE AVAILABLE APPARENTLY. STAFF GAVE HIM A TELEFLEX AE05 PRODUCT INSTEAD TO CONTROL BLEEDING. THE DOCTOR HAD NEVER USED THIS DEVICE BEFORE. HE SAID THAT HE PRACTICED CLOSING AND FIRING THE DEVICE OUTSIDE THE PATIENT TO GET A FEEL FOR THE DEVICE. HE THEN PLACED THREE HOL CLIPS ON THE BLEEDING STRUCTURES. HE SAID STRUCTURES WERE SMALL AND POSSIBLY SMALLER THAN 3MM. HE EXAMINED THE PATIENT BEFORE FINISHING THE PATIENT AND STATED THE PATIENT WAS DRY, MEANING NO VISUAL BLEEDING. SINCE THERE WAS NO INDICATION OF PROBLEMS STAFF THREW AWAY AE05 DEVICE SINCE IT IS DISPOSABLE. HE STATED THAT TWO DAYS LATER THE PATIENT WAS COMPLAINING OF PAIN AND BROUGHT BACK TO OR. THE PATIENT HAD BLOOD IN BELLY AND HAD TO BE GIVEN TWO UNITS OF BLOOD. ONCE BLOOD WAS CLEANED OUT HE COULD SEE THAT BLOOD WAS COMING FROM AREA HE PUT HOL CLIPS. HE ALSO SAID THE CLIPS WERE APPARENTLY OPEN AND, IN THE ABDOMEN, STILL. PATIENT WAS STABILIZED AND IS DOING WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965371 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention