BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRILE FORCEPS CVD 140MM

    MDR report key: 12747460 · Received November 3, 2021

    Report

    Report Number
    9610612-2021-00728
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Report Date
    December 2, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    HRQ
    UDI-DI
    04038653025800
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS CASE (B)(4) WILL BE CLOSED AS A DOUBLETTE OF (B)(4). THEREFORE IT IS NO LONGER REPORTABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS TO AESCULAP AG THAT A CRILE FORCEPS CVD 140MM (PART # BH145R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CRILE FORCEPS BROKE WHICH CAUSED A CATHETER TO SLIP AND EFFECTED THE SURGERY. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00726 (400533509 BH145R), 9610612-2021-00727 (400533511 BH145R), 9610612-2021-00687 (400530950 BH145R).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645815 CRILE FORCEPS CVD 140MM GENERAL SURGICAL INSTRUMENTS HRQ AESCULAP AG BH145R 04038653025800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown