BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 14003801 · Received April 4, 2022

    Report

    Report Number
    2027111-2022-00541
    Event Type
    Injury
    Date Received
    April 4, 2022
    Report Date
    May 10, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF THE HARM RESULTING FROM THIS FAILURE HAS BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAVH OR SALPINGECTOMY. EVENT DESCRIPTION: EVENT DATE IS UNKNOWN. COMPLAINT 1 OF 2: #2022-000768. COMPLAINT 2 OF 2: #2022-000769. LIMITED INFORMATION AVAILABLE. EB210 OR EB215 WAS USED IN EITHER LAVH OR SALPINGECTOMY FOR TWO SEPARATE CASES. PATIENT UNDERWENT REOPERATION DUE TO BLEEDING. TYPE OF INTERVENTION: NI. PATIENT STATUS: NI.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAVH OR SALPINGECTOMY EVENT DESCRIPTION: EVENT DATE IS UNKNOWN. COMPLAINT 1 OF 2: #2022-000768, COMPLAINT 2 OF 2: #2022-000769. LIMITED INFORMATION AVAILABLE. EB210 OR EB215 WAS USED IN EITHER LAVH OR SALPINGECTOMY FOR TWO SEPARATE CASES. PATIENT UNDERWENT REOPERATION DUE TO BLEEDING. TYPE OF INTERVENTION: NI. PATIENT STATUS: NI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620918 UNK ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H GENERATOR