BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS

    MDR report key: 12976889 · Received December 10, 2021

    Report

    Report Number
    2134070-2021-00027
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Report Date
    December 8, 2021
    Manufacturer
    STERILMED, INC.
    Product Code
    NLQ
    UDI-DI
    10888551045247
    PMA / PMN Number
    K182272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND THE BLADE OF THE DEVICE BROKE OFF DURING THE PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION. NONE OF THE ORIGINAL PACKAGING MATERIALS, LABEL OR ORIGINALLY SUPPLIED TORQUE WRENCH WERE RETURNED. THE RETURNED DEVICE WAS EXAMINED. THE DEVICE SERIAL NUMBER IS (B)(6) WHICH LINKS IT TO LOT 2122083. THERE WAS NO OBSERVED STRUCTURAL DAMAGE TO THE HOUSING OR SHAFT OF THE DEVICE. IT WAS OBSERVED THAT THE JAW HINGE AND THE PROXIMAL AREA OF THE TISSUE PAD WAS COVERED IN ESCHAR AND DRIED BIOLOGICAL CONTAMINANTS; INDICATIVE OF PATIENT CONTACT. THE TISSUE PAD APPEARS IN PROPER POSITION, WHOLE AND INTACT. THE METAL BLADE WAS BROKEN IN TWAIN. THE DETACHED PIECE WAS EXAMINED UNDER MAGNIFICATION. THERE ARE OBSERVED SCRATCHES AND GOUGING IN SPOTS ON THE DETACHED PIECE. THE BROKEN EDGE WAS JAGGED AND NOT SMOOTH. THIS CONFIRMS THE REPORTED ISSUE, HOWEVER IT WAS UNDETERMINED WHAT MAY HAVE CAUSED THIS DAMAGE, THOUGH THIS IS INDICATIVE OF CONTACT WITH SOME TYPE OF HARD OR METALLIC OBJECT DURING USE. PER THE INSTRUCTIONS FOR USE, REPROCESSED HARMONIC ACE® +7 SHEARS WITH AH "AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE INSTRUMENT IS ACTIVATED. CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES." AND "CAUTION: SCRATCHES ON THE BLADE MAY LEAD TO PREMATURE BLADE FAILURE. AVOID ACCIDENTAL CONTACT WITH OTHER INSTRUMENTS DURING USE." IT WAS PLUGGED INTO GENERATOR G11 (GEN11 - SOFTWARE VERSION 2016-1.1). THE GENERATOR NOTED IT WAS IDENTIFYING THE DEVICE, BUT THEN DISPLAYED THE MESSAGE "NO INSTRUMENT USES REMAINING". THE DEVICE WAS DISCONNECTED AND RE-ATTACHED, AND IT RESULTED IN THE SAME DISPLAY. DEVICE HAS BEEN USED AND HAS REACHED ITS END OF LIFE. THE ACCOUNT DIDN'T NOTE ANY GENERATOR ERRORS. THE DEVICE HISTORY RECORD FOR LOT 2122083 WAS REVIEWED, AND THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO BEING DISTRIBUTED TO THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AS THERE WERE NO IDENTIFIED INTERNAL ACTIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    EXACT EVENT DATE IS UNKNOWN; HOWEVER, IT WAS IN 2021. THE PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND THE BLADE OF THE DEVICE BROKE OFF DURING THE PROCEDURE. THE BLADE WAS REMOVED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876661 HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS SCALPEL, ULTRASONIC, REPROCESSED NLQ STERILMED, INC. HARH36R 10888551045247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown