BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAUTERY DEVICE IN ACH VITRECTOMY PACK

    MDR report key: 6587196 · Received May 24, 2017

    Report

    Report Number
    1423395-2017-00017
    Event Type
    Injury
    Date Received
    May 24, 2017
    Report Date
    May 24, 2017
    Manufacturer
    KIRWAN SURGICAL PRODUCTS LLC
    Product Code
    OJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PLASTIC PROTECTOR COVERING THE TIP IS DIFFICULT TO REMOVE. THIS RESULTED IN THE TIP BECOMING LOOSE DURING THE REMOVAL OF THE COVER. THE TIP BECAME DISLODGED FROM THE CAUTERY DEVICE DURING THE PROCEDURE AND MADE A TEAR IN THE PATIENTS' RETINA. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION. THE SAMPLE HAS NOT BEEN RETURNED. KIRWAN SURGICAL PRODUCTS LLC IS THE MANUFACTURER OF THIS DEVICE. KIRWAN SURGICAL PRODUCTS LLC HAS BEEN NOTIFIED AND WILL CONDUCT AN INVESTIGATION AND MAKE THE DETERMINATION WHETHER ANY CORRECTIVE ACTION IS INDICATED. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED. SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE CAUTERY DEVICE CAUSED A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370794 CAUTERY DEVICE IN ACH VITRECTOMY PACK OJK KIRWAN SURGICAL PRODUCTS LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention