BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRILE FORCEPS CVD 140MM

    MDR report key: 18291816 · Received December 8, 2023

    Report

    Report Number
    2916714-2023-00122
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    November 1, 2023
    Report Date
    January 31, 2024
    Manufacturer
    AESCULAP AG
    Product Code
    HRQ
    UDI-DI
    04038653025800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE INVESTIGATION WAS UPDATED AND REVIEW OF THE PHOTOGRAPH WAS INCLUDED. INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. A PHOTO WAS PROVIDED AND EXAMINED ; THE BROKEN JAW CAN BE RECOGNIZED. DEVICE HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND THE PRODUCTS WERE FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. REVIEW OF DEVICE HISTORY SHOWED THERE ARE TWO (2) OTHER SIMILAR COMPLAINTS WITHIN THIS BATCH. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR 803, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON: - SERIOUS INJURY (REPORT NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. CONCLUSION/PREVENTIVE MEASURES: BASED UPON THE ABOVE MENTIONED INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE REPORTED DAMAGE OF THE PRODUCT WAS CONFIRMED VIA PHOTO. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THE AVAILABLE LOT NUMBER; THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF PRODUCTION. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. THAT A CRILE FORCEPS CVD 140MM (PART# BH145R) WAS USED DURING A CESAREAN PROCEDURE ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE DEVICE HAD BROKE DURING THE PROCEDURE. THE FRAGMENT WAS ABLE TO BE RETREIVED AND AN X-RAY WAS PERFORMED ON THE PATIENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213242 CRILE FORCEPS CVD 140MM HAEMOSTATIC FORCEPS HRQ AESCULAP AG BH145R 4509387361 04038653025800

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention