BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECONO STERILE¿

    MDR report key: 21491864 · Received February 28, 2025

    Report

    Report Number
    2431166-2025-00001
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    December 18, 2024
    Report Date
    February 20, 2025
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    GEN
    Removal / Correction Number
    RES #95946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARDIAC SURGERY CENTER OF ARIZONA REPORTED THAT A (B)(6) -YEAR-OLD PATIENT WAS ADMITTED POST-SURGERY TO A HOSPITAL WITH AN INFECTION. THE SURGERY CENTER PERFORMED A PACEMAKER LEAD REVISION PROCEDURE ON THE PATIENT ON (B)(6) 2024. THE MANUFACTURER OF SURGICAL INSTRUMENTS USED DURING THE SURGICAL PROCEDURE INITIATED A VOLUNTARY PRODUCT RECALL (RECALL REFERENCE NUMBER 2431166-12/03/24-001-R) ON (B)(6) 2024. CARDIAC SURGERY CENTER OF ARIZONA RECEIVED THE RECALL NOTICE FROM ITS MEDICAL DEVICE DISTRIBUTOR ON 30 DECEMBER 2024. THREE INSTRUMENTS ON THE MANUFACTURER'S RECALL LIST WERE USED DURING THE PACEMAKER LEAD REVISION PROCEDURE ON THE PATIENT: 1.) 96-2563 ECONO STERILE¿ KELLY HEMOSTATIC FORCEPS 5 1/2" CURVED, LOT FSF5. 2.) 96-2531 ECONO STERILE¿ MAYO DISSECTING SCISSORS 5 1/2" STR., LOT FSS5. 3.) 96-2571 ECONO STERILE¿ ADSON DRESSING FORCEPS 4 3/4" STR., LOT SK-115. THE INCIDENT WAS REPORTED TO THE MANUFACTURER ON 22 JANUARY 2025 BY AN X-RAY/SCRUB TECHNICIAN AT THE CARDIAC SURGERY CENTER OF ARIZONA. A PHONE CALL WAS HELD BETWEEN THE TECHNICIAN AND THE MANUFACTURER'S DIRECTOR OF QUALITY AND REGULATORY AFFAIRS ON 23 JANUARY 2025 REGARDING THE CASE. THE TECHNICIAN STATED THAT THE PATIENT CASE WAS A PACEMAKER LEAD REVISION AND THAT THE DOCTOR WOULD RESPOND WITH ADDITIONAL CASE DETAILS. THE RESPONSE WAS RECEIVED FROM THE DOCTOR ON 04 FEBRUARY 2025. THE DOCTOR STATED THE PROCEDURE WAS NORMAL AND THE PATIENT RESPONDED NORMALLY TO THE PROCEDURE WITH NOTHING UNUSUAL NOTED ABOUT HER RECOVERY, HOWEVER THE PACEMAKER SITE NEVER HEALED COMPLETELY. THE PATIENT REPORTED OOZING FROM THE DEVICE SITE 4 WEEKS AFTER THE IMPLANT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS RECENTLY DISCHARGED FROM THE HOSPITAL WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690860 ECONO STERILE¿ KELLY HEMOSTATIC FORCEPS 5 1/2" CURVED GEN SKLAR INSTRUMENTS 96-2563 FSF5

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Hospitalization