BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE+7 SHEARS 5MM X 36CM

    MDR report key: 11841433 · Received May 18, 2021

    Report

    Report Number
    3032391-2021-00008
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 18, 2021
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE OPERATING ROOM TEAM NOTICED THE "TEFLON PAD WAS EITHER MELTED OR MISSING." THE SURGEON SEARCHED INSIDE THE PATIENT FOR THE MISSING PAD. SALES REPRESENTATIVE, MEDLINE INDUSTRIES, INC., REPORTED THAT ON (B)(6) 2021, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE OPERATING ROOM (O.R.) TEAM NOTICED THE TEFLON PAD WAS EITHER MELTED OR MISSING. DR. (B)(6) WAS THE SURGEON DOING THE PROCEDURE. HE SEARCHED INSIDE THE PATIENT FOR A MISSING PAD AND WAS UNABLE TO LOCATE ONE AND THEY BELIEVE THE PAD IS JUST MELTED BADLY. THERE WAS A LOT OF SMOKE COMING FROM THE DISTAL TIP OF THE HARMONIC." THERE WAS NO REPORT OF SERIOUS OR PATIENT INJURY. THE SAMPLE WAS RETURNED AND EVALUATION COMPLETED. DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MED WATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. INVESTIGATION: ON (B)(6) 2021, 15:46:37 CST ((B)(6)). "ONE DEVICE WAS RECEIVED FROM (B)(6) HOSPITAL ON (B)(6) 2021. THE DEVICE WAS CONFIRMED TO BE AN ETHICON HARMONIC ACE+7 SHEARS W/ ADV. HEMOSTASIS USE ONLY W/(B)(4) AND LOWER 5MM X 36CM, PART # HARH36. THE MEDLINE RENEWAL PACKAGE WAS RETURNED WITH THE DEVICE. THE LOT NUMBER ASSOCIATED WITH THE RECEIVED DEVICE WAS 454539. UPON INSPECTION OF THE DEVICE HANDLE, IT WAS OBSERVED THAT THE DEVICE HAD ONE MEDLINE RENEWAL REPROCESSING MARK. DURING THE INVESTIGATION, THE DEVICE WAS INSPECTED FOR NON-CONFORMITIES. UPON INSPECTION, IT WAS OBSERVED THAT THE TEFLON PAD ON THE DISTAL TIP WAS MISSING. ADDITIONALLY, DAMAGE WAS OBSERVED ON THE DEVICE TIP. IT WAS NOTED THAT THERE WAS AN EXCESSIVE AMOUNT OF CHARRING/BURNING ON THE DEVICE JAWS. THE REPORTED ISSUE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT 454539. THE REVIEW INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE LOT WAS PROCESSED. AN INTERNAL STOCK CHECK WAS PERFORMED FOR LOT 454539. NO HARH36 DEVICES FROM THIS LOT REMAIN AT MEDLINE RENEWAL. ROOT CAUSE: THE EXACT ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. UPON REVIEW OF THE MAUDE DATABASE FOR THE HARH36, APPROXIMATELY 330 ADVERSE EVENTS WERE REPORTED BY THE ORIGINAL EQUIPMENT MANUFACTURER FROM 10/1/2020 - 4/30/2021. THE MAJORITY OF THESE EVENTS WERE RELATED TO AN ISSUE WITH THE TIP OF THE DEVICE, OR THE TEFLON PAD MELTING/FALLING OFF. THIS INDICATED THAT THIS IS AN OEM ISSUE AND NOT A DEFECT SOLELY CAUSED BY REPROCESSING. THIS IS THE FIRST COMPLAINT REGARDING TIP/TEFLON PAD DAMAGE WITH A MEDLINE RENEWAL REPROCESSED HARH36. CONCLUSIONS: THE RECEIVED DEVICE WAS INSPECTED PER INTERNAL PROCEDURE. UPON INSPECTION, IT WAS OBSERVED THAT THE TEFLON PAD ON THE DISTAL TIP WAS MISSING. ADDITIONALLY, DAMAGE WAS OBSERVED ON THE DEVICE TIP. IT WAS NOTED THAT THERE WAS AN EXCESSIVE AMOUNT OF CHARRING/BURNING ON THE DEVICE JAWS. THE REPORTED ISSUE WAS CONFIRMED."

    Description of Event or Problem · 1

    IT WAS REPORTED THE OPERATING ROOM TEAM NOTICED THE "TEFLON PAD WAS EITHER MELTED OR MISSING." THE SURGEON SEARCHED INSIDE THE PATIENT FOR THE MISSING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742504 HARMONIC ACE+7 SHEARS 5MM X 36CM LFL MEDLINE RENEWAL 454539

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention