BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENOTOMY SCISSOR

    MDR report key: 4369877 · Received November 13, 2014

    Report

    Report Number
    1055892-2014-00001
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 9, 2014
    Report Date
    November 13, 2014
    Manufacturer
    AESCLAP
    Product Code
    HRR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEFECTIVE DEVICE WAS SENT TO OEM FOR COMPREHENSIVE INVESTIGATION ON 10/15/2014 UNDER THE RETURN AUTHORIZATION # (B)(4). WE WERE NOTIFIED ON 11/12/2014 THAT THE ACTUAL DEVICE WAS SENT TO AESCULAP ((B)(4)) FOR DETAILED INVESTIGATION. INVESTIGATIONAL RESULTS HAVE NOT BEEN PROVIDED AS OF TODAY.

    Description of Event or Problem · 1

    WHILE USING THE TENOTOMY SCISSOR DURING A PODIATRY PROCEDURE, THE TIP OF ONE OF THE SCISSOR BLADES BROKE OFF AND IT WAS BELIEVED TO HAVE FALLEN ON THE FLOOR. AFTER THE PROCEDURE WAS COMPLETED, AN X-RAY WAS PERFORMED TO CONFIRM THAT THE TIP WAS NOT IN THE PT OR SURGICAL INCISION. THERE WAS NO INJURY TO THE PT OR USER AND NO ADDITIONAL MEDICAL INTERVENTION OR MEDICINE DUE TO THE INCIDENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735588 TENOTOMY SCISSOR TENOTOMY SCISSOR HRR AESCLAP DO250R 714887001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention