BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS

    MDR report key: 12228123 · Received July 27, 2021

    Report

    Report Number
    2134070-2021-00016
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 30, 2021
    Report Date
    July 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

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY PROCEDURE WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND THE BLADE BROKE OFF AND FELL IN THE PATIENT. IN THE INITIAL REPORT, IT WAS NOTED THE DEVICE WAS RETURNED. DURING INVESTIGATION IT WAS DETERMINED THE DEVICE RETURNED WAS NOT FOR THIS COMPLAINT. THE DEVICE FOR THIS COMPLAINT WAS DISCARDED. WE COULD NOT CONFIRM THE REPORTED ISSUE BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RECEIVED FOR EVALUATION. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE VISUAL AND FUNCTIONAL INSPECTIONS COULD NOT BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED FOR THE FINISHED DEVICE LOT 2122197 AND NO NONCONFORMANCES WERE IDENTIFIED. 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 · 1

    THE PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY PROCEDURE WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND THE BLADE BROKE OFF AND FELL IN THE PATIENT. THE BLADE WAS REMOVED. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS EVENT HAS BEEN ASSESSED AS AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126013 HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS SCALPEL, ULTRASONIC, REPROCESSED NLQ STERILMED, INC. HARH36R 2122197 10888551045247

    Patients

    Seq Age Sex Outcome Treatment
    1