BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-HALSTED FORCEPS DEL CVD 125MM

    MDR report key: 10586347 · Received September 25, 2020

    Report

    Report Number
    9610612-2020-00574
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Report Date
    December 11, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    HRQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WE MADE A VISUAL INSPECTION OF THE PRODUCT AND OF THE FRACTURE SURFACE. HERE WE FOUND RAINBOW COLORED DISCOLORATION AND YELLOW-BROWN, BROWN AND BLUE DISCOLORATIONS, CRACKS, SECONDARY DAMAGES AND SIGNS OF AN INTERCRYSTALLINE FRACTURE. ADDITIONALLY WE MADE AN OPTICAL INSPECTION OF THE BROKEN OFF PART. HERE WE DETECTED DIFFERENT CHAMFERS. FURTHERMORE WE MADE A VISUAL INSPECTION OF THE FRACTURE SURFACE. HERE WE FOUND BROWN, BLUE AND DARK DISCOLORATION, CRACKS AND SIGNS OF AN INTERCRYSTALLINE FRACTURE. BASED ON THE INFORMATION AVAILABLE, A FINAL ROOT CAUSE COULD NOT BE DETERMINED. THERE MIGHT BE A COMBINATION OF A MULTIPLE FACTORS ERROR THAT LEADS TO THE FRACTURE.

    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 MICRO-HALSTED FORCEPS. ACCORDING TO THE COMPLAINT DESCRIPTION THE TIP BROKE DURING SURGERY. NO COMPLICATIONS DURING SURGERY ANOTHER INSTRUMENT WAS USED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052545 MICRO-HALSTED FORCEPS DEL CVD 125MM HAEMOSTATIC FORCEPS HRQ AESCULAP AG BH109R

    Patients

    Seq Age Sex Outcome Treatment
    1