BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO PITUITARY

    MDR report key: 10982876 · Received December 10, 2020

    Report

    Report Number
    3002631959-2020-00001
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    May 1, 2017
    Report Date
    December 10, 2020
    Manufacturer
    GEBRUEDER ZEPF MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE REGULAR EVALUATION OF COMPLAINTS, NO TREND CAN BE IDENTIFIED THAT WOULD INDICATE A CONSTRUCTIVE PROBLEM WITH THE INSTRUMENTS CONCERNED. OVERLOADING AND INCORRECT HANDLING, I.E. USER ERRORS, CAN LEAD TO THE JAWS BREAKING.

    Description of Event or Problem · 1

    DURING A SURGERY IN 2017 A SURGEON MISUSED A SURGICAL INSTRUMENT, AND/OR USED A DEFECTIVE SURGICAL INSTRUMENT IDENTIFIED IN THE OPERATIVE REPORT AS A KERRISON RONGEUR/UPBITING MICROPITUITARY, WHICH WAS MANUFACTURED BY DEFENDANT MEDTRONIC SOFAMOR DANEK USA, INC., AND IS IDENTIFIED WITH PART #9569567. DUE TO NEGLIGENCE AND CARELESSNESS OF THE SURGEON, A PART OF THE JAW OF THE RONGEUR/UPBITING MICROPITUITARY BROKE OFF, RESULTING IN A TRAUMATIC INJURY TO THE RIGHT COMMON ILIAC ARTERY AND THE INFERIOR VENA CAVA WITH RETROPERITONEAL HEMORRHAGE ACCOMPANIED BY LOSS OF APPROXIMATELY 800 ML OF BLOOD, AND SEVERE HYPOTENSION DUE TO THE NEGLIGENT AND EARLESS DELAY BY THE SURGEON IN RECOGNIZING AN INJURY HAD OCCURRED AND MANAGING PATIENT INJURY AND EXPEDITING CARE FOR THE VASCULAR INJURY. THE SURGICAL PROCEDURE WAS EVENTUALLY ABORTED AND THE PATIENT WAS THEN EMERGENTLY TRANSFERRED TO (B)(6) MEDICAL CENTER FOR TREATMENT OF HER LIFE THREATENING INTRA-OPERATIVE INJURY AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451860 MICRO PITUITARY MICRO PITUITARY LXH GEBRUEDER ZEPF MEDIZINTECHNIK GMBH & CO. KG VARIOUS VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R