BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR

    MDR report key: 16349583 · Received February 10, 2023

    Report

    Report Number
    9610773-2023-00461
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    November 2, 2022
    Report Date
    April 18, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FGA
    UDI-DI
    04042761023214
    PMA / PMN Number
    K853486
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO A1, B3, D8, E1, E2, E3 AND G2 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED ON THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE PATIENTS' OUTCOME AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED ABOUT A LITERATURE STUDY THAT WAS CONDUCTED TO PREDICT STONE FREE RATE AND COMPLICATION RATE FOLLOWING MINI-PERCUTANEOUS NEPHROLITHOTOMY (M-PCNL) USING THE STONE NEPHROLITHOMETRY SCORE IN 106 PATIENTS. THE FOLLOWING PATIENT IMPAIRMENT WAS RECORDED IN THE COURSE OF THIS STUDY: [MODIFIED CLAVIEN GRADING GRADE I]. BLEEDING MANAGED WITH SINGLE EPISODE OF NEPHROSTOMY CLAMP - 7 PATIENTS. POST-OPERATIVE PAIN MANAGED WITH OPIOID ANALGESICS - 5 PATIENTS. POST-OPERATIVE FEVER MANAGED WITHOUT CHANGE IN ANTIBIOTICS - 1 PATIENT. DERANGED RENAL FUNCTION MANAGED WITH IV FLUIDS ONLY - 1 PATIENT. [MODIFIED CLAVIEN GRADING-GRADE II]. POST-OPERATIVE FEVER MANAGED WITH CHANGE IN ANTIBIOTICS - 6 PATIENTS . CULTURE-POSITIVE URINARY TRACT INFECTION - 1 PATIENT. [MODIFIED CLAVIEN GRADING-GRADE III A]. BLEEDING MANAGED WITH MULTIPLE BLADDER IRRIGATION/WASHOUT - 3 PATIENTS. BLEEDING REQUIRING MULTIPLE EPISODES OF NEPHROSTOMY CLAMP>4 H APART - 1 PATIENT. PNEUMOTHORAX MANAGED WITH INTERCOSTAL DRAINAGE - 1 PATIENT. HOWEVER, THERE WAS NO REPORT ABOUT A MALFUNCTION OF AN OLYMPUS DEVICE AND NO CONNECTION OF AN OLYMPUS DEVICE TO AN ADVERSE EVENT WAS REPORTED IN THE LITERATURE. PLEASE NOTE THAT THE NAMED TELESCOPE WAS NAMED AS A REPRESENTATIVE DEVICE SINCE THE ACTUAL MODEL NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43193 OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR OP TELESCOPES, AUTOCLAVABLE (WITH CHANNEL) FGA OLYMPUS WINTER & IBE GMBH A37025A 04042761023214

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown