BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FORCEPS

    MDR report key: 15539936 · Received October 4, 2022

    Report

    Report Number
    3014334038-2022-00220
    Event Type
    Injury
    Date Received
    October 4, 2022
    Report Date
    October 21, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HRQ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP WAS MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE INITIAL REPORTER AND END-USERS. AS PER HOSPITAL STAFF, NO ONE WAS AWARE AS TO WHY THE REPORT WAS SENT TO INTEGRA FROM HEALTH CANADA. IT WAS NOTED THAT THE HOSPITAL HAD PREVIOUSLY PURCHASED THE SUSPECTED GREEN ARMYTAGE FORCEPS AND CRILE FORCEPS FROM INTEGRA, TELEFLEX AND AMT; THEREFORE, THE SUSPECTED PRODUCT MAY NOT BE AN INTEGRA PRODUCT. AFTER CAREFUL REVIEW OF OUR SYSTEM, INTEGRA COULD NOT LOCATE PRODUCTS WITH REPORTED DEVICE ID 811300. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE REPORTED CRILE HEMOSTATIC FORCEPS (811300) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED. THE REPORTED PRODUCT ID DOES NOT MATCH ANY INTEGRA PRODUCT; THUS, MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE DEVICE'S IDENTITY AND MANUFACTURER IS UNKNOWN, AND THE PRODUCT IS NOT AVAILABLE FOR RETURN. DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE ISSUE SNAPPING DURING USE MAY BE THE RESULT OF ROUGH HANDLING OR ENVIRONMENTAL DAMAGE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED VIA CANADA VIGILANCE - MEDICAL DEVICE PROBLEM REPORTING PROGRAM / REFERENCE NUMBER (B)(4): IT WAS REPORTED THAT THE PATIENT WAS RECEIVING A CAESARIAN SECTION. GREEN-ARMYTAGE FORCEPS WAS USED TO CLOSE THE UTERUS WHEN ONE OF THE DISTAL ARMS OF THE FORCEPS SNAPPED OFF COMPLETELY AND FELL INTO THE UTERINE CAVITY. THE UTERUS WAS REOPENED AND THE METAL PART WAS RETRIEVED AND ALL PARTS OF THE FORCEPS WAS ACCOUNTED FOR.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257558 UNKNOWN FORCEPS N/A HRQ INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 Female