BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    MDR report key: 7971989 · Received October 16, 2018

    Report

    Report Number
    3005075853-2018-13663
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    September 27, 2018
    Report Date
    October 29, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036015055
    PMA / PMN Number
    K160752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MDR DECISION IS NOW NOT REPORTABLE. ADDITIONAL INFORMATION WAS OBTAINED: ADDITIONAL INFORMATION OBTAINED FROM JJM REP: CONFIRMED IT WAS DURING USE ON PATIENT. CASE MORE COMPLICATED THAN HE (SURGEON) THOUGHT FOR LAPROSCOPIC. JJM REP HAD A DEVICE ON HAND TO CHANGE TO, BUT HE (SURGEON) SAID "I WAS GOING TO CHANGE TO OPEN ANYWAY." JJM REP CONFIRMED IT WAS NOT DEVICE ISSUE THAT CAUSED THE SURGEON TO CHANGE TO OPEN. UPON REVIEW OF THE ADDITIONAL INFORMATION PROVIDED (THAT THE SURGEON/HEALTHCARE PROFESSIONAL CONFIRMED THAT IT WAS NOT A DEVICE ISSUE THAT CAUSED THE SURGEON TO CHANGE TO AN OPEN PROCEDURE), IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS NOW BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO OBTAIN THE FOLLOWING INFORMATION, NO RESPONSE TO DATE. SHOULD INFORMATION BECOME AVAILABLE, SUPPLEMENTAL REPORT WILL BE SENT: APPROXIMATELY HOW LONG WAS DEVICE USED BEFORE THE USER RECEIVED THE CLEAN INSTRUMENT ALERT SCREEN? WERE ANY OTHER ALERT SCREENS RECEIVED PRIOR TO CLEAN INSTRUMENT ALERT SCREEN? DID OPERATING STAFF TRY ANOTHER DEVICE PRIOR TO CONVERTING PROCEDURE TO OPEN PROCEDURE? WHAT WAS THE REASON THEY DECIDED TO CONVERT TO AN OPEN PROCEDURE? DID DIFFICULTIES EXPERIENCED WITH DEVICE DURING THE PROCEDURE FACTOR INTO SURGEON¿S DECISION TO CONVERT PROCEDURE TO OPEN? BEFORE DEVICE WAS ACTIVATED FOR BLADE INTEGRITY TEST, HOW WAS DEVICE CLEANED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC REVERSAL OF HARTMANN¿S, THE DEVICE WAS PLUGGED INTO THE GEN11 AND ERROR READING SAID ¿ CLEAN INSTRUMENT¿ AND WHEN REACTIVATED ERROR READING SAID ¿CHANGE INSTRUMENT¿. THE DEVICE WAS UNPLUGGED AND RE-PLUGGED IN AND THE MESSAGE WAS THE SAME. NO ADVERSE OUTCOME AS SURGERY WAS CONVERTED TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812955 HARMONIC HD 1000I SHEARS 36CM SHAFT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. 10705036015055

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GENERATOR