BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL PURPOSE TEMPERATURE PROBE

    MDR report key: 7052593 · Received November 22, 2017

    Report

    Report Number
    9613793-2017-00006
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    October 27, 2017
    Report Date
    November 22, 2017
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
    Product Code
    FLL
    PMA / PMN Number
    K925791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE INVESTIGATION IDENTIFIED THE ROOT CAUSE AS A USE ERROR IN THE PLACEMENT OF THE PROBE. THE PROBE IS INTENDED TO BE PLACED IN THE ESOPHAGUS, BUT IT IS NOT INTENDED TO GO INTO THE STOMACH. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY. AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT A GENERAL PURPOSE TEMPERATURE PROBE (PART NUMBER 81-020409EU, LOT 44557628) WAS INSERTED THROUGH A PATIENT'S ESOPHAGUS INTO THE STOMACH WHERE IT WAS SURGICALLY STAPLED. THE PATIENT UNDERWENT A SECOND SURGERY TO REMOVE THE PROBE. A SAMPLE WAS NOT AVAILABLE FOR RETURN; THEREFORE, A VISUAL INSPECTION AND EVALUATION COULD NOT BE PERFORMED. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE DRAWING WAS REVIEWED AND IT WAS CONFIRMED THE PROBE TUBING WAS WITHIN THE SPECIFIED LENGTH. ADDITIONALLY, INCOMING INSPECTION DOCUMENTS OF THE TUBING USED IN PRODUCTION OF THE REPORTED LOT CONFIRMED THAT ALL TOTAL LENGTH RESULTS WERE WITHIN SPECIFICATION. ADDITIONALLY, DEROYAL OFFERS GENERAL PURPOSE TEMPERATURE PROBES WITH PRINTED DEPTH MARKINGS ON THE TUBING THAT ARE PLACED EVERY 5 CENTIMETERS. THE INSTRUCTIONS FOR USE STATE THE PROBE IS INTENDED TO BE PLACED IN THE NASAL OR NASOPHARYNX CAVITIES, INTO THE ESOPHAGUS, OR INTO THE RECTUM. ADDITIONALLY, IT STATES, TO VERIFY PROPER PLACEMENT OF A PROBE USED IN THE ESOPHAGUS, A LARYNGOSCOPE SHOULD BE USED. A TWO-YEAR REVIEW OF COMPLAINTS WAS COMPLETED AND NO SIMILAR EVENTS HAVE BEEN REPORTED. PREVENTIVE ACTION: A CORPORATE CORRECTIVE AND PREVENTIVE ACTION ((B)(4)) HAS BEEN OPENED TO EVALUATE IF ALL GENERAL PURPOSE PROBES SHOULD SHOW DEPTH MARKINGS ON THE TUBING. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    AN END USER INSTERTED A GENERAL PURPOSE TEMPERATURE PROBE VIA THE ESOPHAGUS AND INTO THE STOMACH WHERE IT WAS ATTACHED TO THE SCENE BY SURGICAL STAPLING. THE PATIENT UNDERWENT A SECOND SURGERY TO RELEASE THE PROBE FROM THE GASTRIC WALL TISSUE. THE END USER SUGGESTED THAT THE PROBE DESIGN WAS TOO LONG AND THE PRODUCT QUALITY MAY BE INCREASED BY PRINTING A NUMERIC SCALE ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831067 GENERAL PURPOSE TEMPERATURE PROBE THERMOMETER, ELECTRONIC, CLINICAL FLL DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. 81-020409EU 44557628

    Patients

    Seq Age Sex Outcome Treatment
    1