BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC HD 1000I SHEARS 20CM SHAFT

    MDR report key: 15472871 · Received September 23, 2022

    Report

    Report Number
    3005075853-2022-06373
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 28, 2022
    Report Date
    September 22, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036015048
    PMA / PMN Number
    K160752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/17/2022. D4 BATCH #: V95M13. THIS IS AN ANALYSIS OF AN IMAGE SUBMITTED FOR EVALUATION. IMAGE 1 (V95M13 21243-0413 20): THE IMAGE PROVIDED BY THE CUSTOMER SHOWS A HARHD INSTRUMENT WITH THE BLADE TIP BROKEN OFF. IMAGE 2 (V95M13 21243-0413 20): THE IMAGE PROVIDED BY THE CUSTOMER SHOWS A HARHD HANDLE. THE BATCH AND SERIAL COULD BE SEEN AS V95M13, 21234-0413. IMAGE 3 (V95M13 21243-0413 20): THE IMAGE PROVIDED BY THE CUSTOMER IS THAT OF THE DISTAL JAW OF WHAT APPEARS TO BE A HARHD INSTRUMENT. A CLOSER LOOK AT THE CLAMP ARM INTERFACE SHOWS THE BLADE TIP BROKE OFF. INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED, AND WITH EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. DURING FUNCTIONAL TESTING ON GEN11, AN ALERT SCREEN WAS DISPLAYED. A PROBABLE CAUSE FOR THE DEVICE TO STOP ACTIVATING AND THE GEN11 TO DISPLAY AN ALERT SCREEN IS BLADE DAMAGE. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS AND NO ANOMALIES WERE FOUND. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE THE SEVERITY OF THE BLADE DAMAGE. THIS IN TURN CAN RESULT IN ACTIVATION ISSUES SUCH AS FAILING THE PRE-RUN TEST WITH THE GENERATOR AND DISPLAYING AN ALERT SCREEN. THESE ALERT SCREENS THAT CAN RESULT ARE SUCH AS "REMOVE INSTRUMENT FROM PATIENT" OR ¿BLADE ERROR DETECTED¿ OR "RELAXED PRESSURE ON BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE. CONTINUED USAGE OF THE DAMAGE BLADE CAN RESULT IN A BROKEN BLADE. AS PART OF THE QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH/LOT. PHOTO IMAGES WERE RECEIVED AND ARE PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE THE TITANIUM TIP WAS BROKEN DURING PROCEDURE. THE BREAKAGE PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727814 HARMONIC HD 1000I SHEARS 20CM SHAFT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. HARHD20 V95M13 10705036015048

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown