BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRILE FORCEPS CVD 140MM

    MDR report key: 12590421 · Received October 7, 2021

    Report

    Report Number
    9610612-2021-00665
    Event Type
    Injury
    Date Received
    October 7, 2021
    Report Date
    May 9, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    HRQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INVESTIGATION: WE MADE A VISUAL INSPECTION OF THE PRODUCT. HERE WE FOUND THE BROKEN INSTRUMENT ON THE JAW MALE. ADDITIONALLY WE FOUND DISCOLORATION ON THE SURFACE OF THE PRODUCT. FURTHERMORE, WE FOUND CORROSION ON THE SURFACE. THE CAUSE OF THE DAMAGE IS DUE TO SEVERAL FACTORS THAT HAVE LED TO THE FRACTURE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 1(5) X PROBABILITY OF OCCURRENCE 1(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY REPROCESSING, MANUFACTURING OR A DESIGN-RELATED FAILURE. BASED ON THE INVESTIGATION RESULTS, A CHANGE WITH APPLICATION NUMBER HAS BEEN INITIATED.

    Additional Manufacturer Narrative · 0

    CORRECTION/ADDITIONAL INFORMATION: SEE B5.

    Additional Manufacturer Narrative · 0

    CORRECTION/ADDITIONAL INFORMATION: B1+B2: ADVERSE EVENT. B5: PATIENT HARM. H1: SERIOUS INJURY. H6: CODES.

    Description of Event or Problem · 0

    ADDITONAL INFORMATION: THIS CASE IS POSSIBLY ASSOCIATED WITH THE REFERENCE NUMBER (B)(4). 9610612-2021-00687 (400530950 BH145R).

    Description of Event or Problem · 0

    CORRECTION: PATIENT HARM CHANGED: ADDITIONAL MEDICAL INTERVENTION NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BH145R-CRILE FORCEPS CVD 140MM. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT THE INSTRUMENT BH145R CRACKED AND SLIPPED OFF THE CATHETER DURING THE CARDIAC SURGERY. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486475 CRILE FORCEPS CVD 140MM GENERAL SURGICAL INSTRUMENTS HRQ AESCULAP AG BH145R 4509437406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention