BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRIS SCISSORS CVD.S/S 110MM

    MDR report key: 15260687 · Received August 19, 2022

    Report

    Report Number
    9610612-2022-00240
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    June 29, 2022
    Report Date
    October 20, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    LRW
    UDI-DI
    04038653020324
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    USER FACILITY MDR REPORT # MW5110783. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    AS PREVIOUSLY REPORTED, INFORMATION RECEIVED VIA ONLINE SUBMISSION FORM MDR MEDWATCH 5110783. INVESTIGATION: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT A LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE BATCH HISTORY COULD NOT BE PERFORMED. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IF THE DEVICE IS RETURNED IN THE FUTURE, AN INVESTIGATION WILL AGAIN BE COMPLETED AT THAT TIME. BASED UPON THE INVESTIGATION RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH IRIS SCISSORS CVD.S/S 110MM - BC061R. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CURVED IRUS SCISSORS BROKE IN THE PATIENT'S NOSE WHILE SURGEON WAS PERFORMING NASAL SURGERY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Description of Event or Problem · 0

    RECEIVED VIA ONLINE SUBMISSION FORM MDR MEDWATCH 5110783.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791166 IRIS SCISSORS CVD.S/S 110MM GENERAL SURGICAL INSTRUMENTS LRW AESCULAP AG BC061R 19063 04038653020324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention