BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS MCO13C ALLIG 3X0.6MM HARTMAN

    MDR report key: 11854403 · Received May 20, 2021

    Report

    Report Number
    2523190-2021-00105
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Report Date
    March 25, 2022
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H10. THE FORCEPS WERE RETURNED FOR EVALUATION: DHR - NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED FAILURE ANALYSIS - THE PIN BETWEEN THE JAWS AND THE SLIDE PART IS MISSING. THE SLIDE PART IS BENT. ROOT CAUSE - THIS ISSUE IS PROBABLY DUE TO AN IMPROPER HANDLING OF THE DEVICE DURING THE FIRST CLEANING OR THE STORAGE.

    Additional Manufacturer Narrative · 0

    MCO13C FORCEPS WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. HOWEVER, THIS ISSUE MAY BE DUE TO A BAD HANDLING OF THE DEVICE DURING THE FIRST CLEANING, A MATERIAL DEFECT OR A MANUFACTURING DEFECT. 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

    N/A.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE FORCEPS MCO13C WAS BROKEN DURING AN UNSPECIFIED PROCEDURE EVEN THOUGH IT WAS NOT TOUCHED ON A HARD PLACE AFTER THE FIRST USE. THERE WAS NO PATIENT INJURY AND NO SURGERY DELAY. HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756286 FORCEPS MCO13C ALLIG 3X0.6MM HARTMAN PFM11 KAE INTEGRA YORK, PA INC. 4453443

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown