BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOS PERFORATOR

    MDR report key: 17483733 · Received August 8, 2023

    Report

    Report Number
    3014334038-2023-00130
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    July 24, 2023
    Report Date
    January 31, 2025
    Manufacturer
    RAYNHAM
    Product Code
    HBF
    UDI-DI
    10381780513599
    PMA / PMN Number
    K791101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE CODMAN PERFORATOR (ID (B)(4)) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) ¿ THE PRODUCT ID (B)(4) WITH LOT 6973693 WAS REVIEWED AND THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL TEST RESULTS PASSED PROCEDURAL SPECIFICATIONS. FAILURE ANALYSIS - THE PERFORATOR UNIT WAS INSPECTED USING THE UNAIDED EYE. THE DEVICE WAS RETURNED DISASSEMBLED, AND EVALUATOR COULD VISUALLY DETECT A SHALLOW WELD (PROUD WELD) ON THE BLUE SLEEVE. INSTRUCTION FOR USE (IFU) TESTING PROCEDURE WAS NOT PERFORMED SINCE THE UNIT COULD NOT BE TESTED IN THE AS-RECEIVED CONDITION. FUNCTIONAL TESTING WAS NOT PERFORMED BECAUSE THE UNIT COULD NOT BE TESTED IN THE AS-RECEIVED CONDITION. THE UNIT WAS FOUND TO NOT MEET SPECIFICATIONS DUE TO THE SHALLOW (PROUD) WELD ON THE BLUE SLEEVE. ROOT CAUSE ANALYSIS - THE COMPLAINT WAS CONFIRMED IN THE COMPLAINT INVESTIGATION. THE LIKELY ROOT CAUSE IS THE SHALLOW WELD ON THE BLUE SLEEVE, HOWEVER AN INVESTIGATION INTO TRUE ROOT CAUSE FOR THIS FAILURE MODE IS BEING CONDUCTED UNDER A CORRECTIVE AND PREVENTATIVE ACTION (CAPA).

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: B1 - INITIALLY REPORTED: "ADVERSE EVENT AND PRODUCT PROBLEM". CORRECTED TO: "PRODUCT PROBLEM". B2 - INITIALLY REPORTED: B2: "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES),". CORRECTED TO: <NONE>.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THE OUTER PLASTIC OF A PERFORATOR (ID 261221) CAME OFF WHEN PULLING OUT AFTER PERFORATING. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO SURGICAL DELAY REPORTED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF ANY PART FELL INTO THE SURGICAL SITE. THE PERFORATOR WAS USED WITH EMAX2PLUS (ANSPACH).

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344028 CODMAN DISPOS PERFORATOR DISPOSABLE PERFORATORS HBF RAYNHAM 6973693 10381780513599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EMAX2PLUS (ANSPACH)