BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOLL THYROID/VAGINAL RETRACTOR 155MM

    MDR report key: 10995067 · Received December 12, 2020

    Report

    Report Number
    9610612-2020-00882
    Event Type
    Malfunction
    Date Received
    December 12, 2020
    Report Date
    March 25, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    HDL
    PMA / PMN Number
    A883097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED UPON NEW INFORMATION RECEIVED, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE - NO MALFUNCTION OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BV087R - OLL THYROID/VAGINAL RETRACTOR 155MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SURGEON WHO USES THIS RETRACTOR HAS NOTICED A DIFFERENCE IN THE DESIGN OF THE CENTRAL SCREW THREAD WHICH ALLOWS THE OPENING TO BE BLOCKED. WITHIN A CERTAIN DISTANCE. AFTER A WHILE THE LOCKING SYSTEM NO LONGER HOLDS AND CLOSES SLOWLY. WHICH IS PROBLEMATIC FOR HIS COMPLEX THYROID SURGERIES. THIS PROBLEM DOES NOT EXIST WITH THE 2 OTHER SPACERS OF THE SAME REFERENCE. THE DESIGN OF THE THREAD LOCKING SYSTEM WAS DIFFERENT. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459628 JOLL THYROID/VAGINAL RETRACTOR 155MM BASIC INSTRUMENTS HDL AESCULAP AG BV087R 4511275822

    Patients

    Seq Age Sex Outcome Treatment
    1