BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUOROSTAR

    MDR report key: 11586514 · Received March 29, 2021

    Report

    Report Number
    9680959-2021-00001
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    January 23, 2021
    Report Date
    September 8, 2021
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH 14 WILHELM-MAISEL-STR
    Product Code
    OWB
    PMA / PMN Number
    K043076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED EVENT HAS CONCLUDED THAT AFTER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER IT WAS CONFIRMED THAT A SERIOUS INJURY DID NOT OCCUR. A REVIEW OF THE EVENT BY THE GE OEC MEDICAL DIRECTOR CONCLUDED THAT, SHOULD THE EVENT RECUR, IT WOULD NOT BE LIKELY TO RESULT IN DEATH OR SERIOUS INJURY. THEREFORE THIS EVENT IS NOT REPORTABLE UNDER 21 CFR 803.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED WHILE PERFORMING A PERCUTANEOUS NEPHROLITHOTOMY, DURING LIVE IMAGE ACQUISITION, THE IMAGE BECAME DARK, THE SYSTEM LOST FUNCTIONALITY AND AN ERROR MESSAGE WAS DISPLAYED PREVENTING THE CONTINUATION OF THE SURGERY. THE CLINICAL TEAM CHOSE TO TERMINATE THE PROCEDURE RESULTING IN PROLONGATION OF HOSPITALIZATION TIME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON A LATER DATE AND THE PATIENT IS RECOVERING AT HOME WITHOUT COMPLICATIONS. GE HEALTHCARES INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED, IF ADDITIONAL INFORMATION IS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE PERFORMING A PERCUTANEOUS NEPHROLITHOTOMY, DURING LIVE IMAGE ACQUISITION, THE IMAGE BECAME DARK, THE SYSTEM LOST FUNCTIONALITY AND AN ERROR MESSAGE WAS DISPLAYED PREVENTING THE CONTINUATION OF THE SURGERY. THE CLINICAL TEAM CHOSE TO TERMINATE THE PROCEDURE RESULTING IN PROLONGATION OF HOSPITALIZATION TIME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON A LATER DATE AND THE PATIENT IS RECOVERING AT HOME WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482430 FLUOROSTAR FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS GMBH 14 WILHELM-MAISEL-STR XMS577 79-C5208D

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization