BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCK1 HD CAMERA HEAD

    MDR report key: 8286648 · Received January 29, 2019

    Report

    Report Number
    1221934-2018-53771
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Report Date
    June 9, 2017
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    FWF
    UDI-DI
    10886705026258
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). PERFORMED SERVICE & REPAIR. NOTHING NOTED IN SERVICE HISTORY REVIEW THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. ATTACHED BOX LABEL, AND SERVICE REPORT FORM. COULD NOT DUPLICATE THE CUSTOMER'S COMPLAINT THAT THE IMAGE CUTS IN AND OUT. MULTIPLE ATTEMPTS TO DUPLICATE THE COMPLAINT WERE MADE, AND THE UNIT PASSED ALL ATTEMPTS. THE UNIT PASSES ALL FUNCTIONAL AND DIAGNOSTIC TESTING AND IS FULLY OPERATIONAL. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 242400, LOT OM01460 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IMAGE ON THE TCK1 HD CAMERA HEAD DEVICE WAS CUTTING IN AND OUT. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78848 TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA FWF DEPUY MITEK LLC US 10886705026258

    Patients

    Seq Age Sex Outcome Treatment
    1