BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENTUBE LACRIMAL INTUBATION SET

    MDR report key: 5746348 · Received June 23, 2016

    Report

    Report Number
    1649914-2016-00031
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    May 25, 2016
    Report Date
    July 20, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    OKS
    UDI-DI
    10634624815527
    PMA / PMN Number
    K113118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE INSPECTION REPORT SHOWED THAT NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE COMPLAINT CONDITION. THE INSPECTION DATA DID NOT SHOW ANY NON-CONFORMANCIES OR ANOMALIES FOR THE INCOMING MATERIAL COMPONENTS FOR THE TUBE OR THE SHRINK TUBING.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN THE DEVICE FOR EVALUATION FROM THE COMPLAINANT ARE ON-GOING. QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL PURCHASING DEPARTMENT REPORTED AN ISSUE ENCOUNTERED BY THE PHYSICIAN WHILE USING THE LACRIMAL INTUBATION SET. THE REPORT STATED THAT PIECES OF THE DEVICE BROKE INTO THE PATIENT'S EYE WHILE THE PHYSICIAN WAS INSERTING IT DURING A RIGHT ENDOSCOPIC DACRYOADENOTOMY. THE REPORT STATED THE SURGICAL SITE WAS EXAMINED TO RETRIEVE THE BROKEN PIECES AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION; IT IS WITH THE HOSPITAL'S CLINICAL ENGINEERING DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399191 STENTUBE LACRIMAL INTUBATION SET LACRIMAL STENT AND INTUBATION SET OKS QUEST MEDICAL, INC. LIS052 0497825G08 10634624815527

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention