BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLASSIC PLUS 36-3010 CODMAN 31, MAYO SZ 1.0 NEEDLE HOLDER

    MDR report key: 16815303 · Received April 26, 2023

    Report

    Report Number
    16815303
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 7, 2023
    Report Date
    April 19, 2023
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS UNDERGOING A BIFRONTAL CRANIOTOMY AT TIME OF CLOSURE A CLASSIC PLUS 36-3010 CODMAN 31, MAYO SZ 1.0 NEEDLE HOLDER WAS BEING USED TO PLACE SUTURES FOR DURAL CLOSURE. DURING THE PLACEMENT OF A SUTURE A PORTION OF THE CARBIDE JAW PLATE BROKE AWAY FROM THE NEEDLE HOLDER AND THE FRACTURED PORTION OF JAW PLATE UNKNOWINGLY FELL INTO THE SURGICAL BED. THIS WAS NOT NOTICED BY THE SURGICAL TEAM, NOR THE OR STAFF INTRAOPERATIVELY, AND CLOSING CONTINUED. THE PROCEDURE WAS FINISHED WITHOUT ISSUE. ALL INSTRUMENT AND NEEDLE COUNTS WERE CORRECT AT THE TIME OF THE CONCLUSION OF THE PROCEDURE. POST PROCEDURE, THE PATIENT UNDERWENT ROUTINE POSTOPERATIVE HEAD CT WHERE A METALLIC OBJECT WAS IDENTIFIED WITHIN THE SURGICAL BED. THE SURGICAL TEAM DETERMINED THIS WAS NOT AN INTENTIONALLY PLACED SURGICAL ITEM. IT WAS DECIDED BY THE SURGICAL TEAM TO TAKE THE PATIENT BACK TO THE OR THE NEXT DAY TO RETRIEVE THE UNKNOWN AND UNINTENTIONALLY RETAINED ITEM. ONCE THE SURGICAL WOUND WAS REOPENED, THEY IDENTIFIED THE OBJECT AS A 9MM CARBIDE PIECE OF THE NEEDLE HOLDER JAW PLATE. THIS WAS REMOVED FROM THE PATIENT. THE DEFECTIVE NEEDLE DRIVER WAS LOCATED, AND THE PIECE RETRIEVED FROM THE PATIENT WAS FIT ONTO THE INSTRUMENT WHICH CONFIRMED THERE WERE NO ADDITIONAL MISSING PIECES. ADDITIONAL HEAD IMAGING WAS OBTAINED AS WELL TO VERIFY NO OTHER METALLIC ITEMS WERE UNINTENTIONALLY RETAINED WITHIN THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610076 CLASSIC PLUS 36-3010 CODMAN 31, MAYO SZ 1.0 NEEDLE HOLDER FORCEPS, GENERAL & PLASTIC SURGERY GCJ SYMMETRY SURGICAL INC. 36-3010

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA Female Required Intervention| O