BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICUT® STRAIGHT SHAFT 4MM 11CM LONG

    MDR report key: 7120650 · Received December 15, 2017

    Report

    Report Number
    1045254-2017-00458
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 17, 2017
    Report Date
    March 12, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS INDICATES ONE OPENED SAMPLE, PART NUMBER 1884002, FROM LOT NUMBER [NO INFORMATION] WAS RECEIVED. THERE WAS A RESIDUE CONSISTENT WITH BIOLOGICAL CONTAMINANTS ON THE DEVICE. ALTHOUGH THE REPORTED PART NUMBER WAS 1884004, THE CONFIGURATION OF THE DEVICE IS CONSISTENT WITH THE PART NUMBER AS STATED ABOVE. THE DISTAL TIP HAD BROKEN OFF THE INNER CUTTER WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT [THE TIP OF THE BLADE HAD BROKEN OFF]. THE PORTION THAT BECAME DETACHED MEASURED APPROXIMATELY 0.25¿ IN LENGTH. THE BREAK OCCURRED AT THE FIRST PROXIMAL TOOTH VALLEY. THERE WAS UNEVEN WEAR AT THE CUTTING TIP WHICH MAY INDICATE AN INTERFERENCE FIT BETWEEN THE INNER AND OUTER ASSEMBLIES AT THE TIP. THERE WAS AN OUT OF SPECIFICATION CONDITION IDENTIFIED AS IT RELATES TO THE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE BLADE HAS NOT BEEN RETURNED FOR EVALUATION. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE DEVICE LOT IS NOT AVAILABLE AS THE PACKAGE WAS DISCARDED. A FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY) WAS PERFORMED. USING THE SCOPE, THE SURGEON WAS ABLE TO IDENTIFY THE FRAGMENT AND RETRIEVED THE FRAGMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE SURGEON INDICATED THE BLADE WAS NOT WORKING. WHEN HE TOOK THE BLADE OUT OF THE PATIENT TO EXAMINE THE BLADE, THE TIP OF THE BLADE HAD BROKEN OFF. THE NURSE SAW THE TIP ON THE ENDOSCOPE MONITOR AND RETRIEVED THE TIP OF THE BLADE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899754 TRICUT® STRAIGHT SHAFT 4MM 11CM LONG BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884004

    Patients

    Seq Age Sex Outcome Treatment
    1