BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRILE FORCEPS CVD 140MM

    MDR report key: 12747459 · Received November 3, 2021

    Report

    Report Number
    9610612-2021-00687
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 5, 2021
    Report Date
    January 13, 2022
    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

    Additional Manufacturer Narrative · 0

    UPDATED B3: DATE OF EVENT BASED UPON UPDATED PRODUCT RISK ANALYSIS, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE - NO MALFUNCTION OR SERIOUS INJURY.

    Description of Event or Problem · 0

    THIS CASE IS NOT ASSOCIATED WITH THE LISTED MEDWATCH REPORTS BELOW. ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00726 (400533509 BH145R) 9610612-2021-00727 (400533511 BH145R) 9610612-2021-00728 (400533513 BH145R) 9610612-2021-00687 (400530950 BH145R) IT IS POSSIBLY ASSOCIATED WITH 400529799.

    Description of Event or Problem · 0

    THIS CASE IS NOT ASSOCIATED WITH THE LISTED MEDWATCH REPORTS BELOW. ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00726 (400533509 BH145R), 9610612-2021-00727 (400533511 BH145R), 9610612-2021-00728 (400533513 BH145R), 9610612-2021-00687 (400530950 BH145R). IT IS POSSIBLY ASSOCIATED WITH (B)(4).

    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), 9610612-2021-00728 (400533513 BH145R), 9610612-2021-00687 (400530950 BH145R).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645814 CRILE FORCEPS CVD 140MM HEMOSTAT HRQ AESCULAP AG BH145R 4509387361 04038653025800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown