BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA OMEGA

    MDR report key: 7306330 · Received March 1, 2018

    Report

    Report Number
    9615126-2018-00001
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    January 31, 2018
    Report Date
    February 28, 2018
    Manufacturer
    ALPHA OMEGA ENGINEERING LTD.
    Product Code
    GZL
    UDI-DI
    07290014954731
    PMA / PMN Number
    K120098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    DISPOSABLE TAPERED CANNULA (PN: STR-000076-10) INVESTIGATION INCLUDED: NINE (9) NEUROSURGERY CENTERS IN EUROPE, ONE (1) CENTER IN CANADA AND ONE (1) CENTER IN USA ARE ROUTINELY USING THE TAPERED CANNULA. ALL, WITH THE EXCEPTION OF INSELSPITAL-SCHUEPBACH (SUBJECT TO THIS REPORT) WERE NOT FACING UNUSUAL BRAIN HEMORRHAGE WHILE USING THE TAPERED CANNULA. RETESTING SAMPLED TAPERED CANNULAS (PN: STR-000076-10) FROM FINISHED GOODS STOCK. CONSULTING WITH 4 NEUROSURGEONS ABOUT POSSIBLE CAUSES THAT MAY CAUSE SEVERE BRAIN HEMORRHAGE DURING DBS PROCEDURE. ALL NEUROSURGEONS ROUTINELY USE ALPHA OMEGA CANNULAS (TWO ARE USING THE SAME CANNULA MODEL). ANALYSIS RESULTS: ALL CANNULAS PASSED TEST CRITERIA BUT SMALL PERCENTAGE OF THE RETESTED CANNULAS, FROM LOT#: 30106, DEMONSTRATED MARGINAL RESULTS IN STRAIGHTNESS TEST CRITERIA, WHICH ACCORDING TO THE NEUROSURGEONS, MAY NOT BE THE CAUSE FOR BRAIN HEMORRHAGE. ACCORDING TO THE NEUROSURGEONS PLANNING INEXACTNESS IS THE MAIN CAUSE FOR HEMORRHAGE. NOTE: THE TAPERED CANNULA IS THE THINNESS IN DIAMETER, THEREFORE IS SENSITIVE TO HANDLING AND SHIPPING CONDITIONS. ACTIONS TAKEN BY ALPHA OMEGA: REMEDIAL ACTION: 1. RECALL IS NOT RELEVANT SINCE THE TAPERED CANNULAS (PN: STR-000076-10, LOT#: 30106) ARE NOT IN THE FIELD ANYMORE, ALPHA OMEGA CONTACTED THE USERS OF THE TAPERED CANNULA AND FOUND THAT THE CANNULAS (PN: STR-000076-10, LOT#: 30106) 2. IMPROVING THE STRAIGHTNESS TEST BY USING AUTOMATED TOOL AND REDUCING ACCEPTANCE RANGE. CORRECTIVE ACTION: REVIEW AND AS APPROPRIATE, IMPROVE THE TAPERED CANNULA HANDLING PROCESSES (I.E. CLEANING, PACKAGING, STORAGE AND SHIPPING) IN ORDER TO IMPROVE PRESERVATION OF THE PRODUCT.

    Description of Event or Problem · 0

    ALPHA OMEGA'S DISPOSABLE STERILE CANNULA FOR NEUROSURGERY, MODEL: TAPERED CANNULA (PN: STR-000076-10) WAS USED DURING A ROUTINE PLACEMENT OF A DBS ELECTRODE NEUROSURGERY PROCEDURE. FOLLOWING THE NEUROSURGERY, THE USER COMPLAINED THAT HE NOTICED UNUSUAL HEMORRHAGE WHICH HE SUSPECTS THAT WAS CAUSED BY THE USE OF ALPHA OMEGA'S DISPOSABLE STERILE CANNULA. NO OTHER ADVERSE NEUROSURGERY OUTCOMES WERE REPORTED. NO REMEDIAL ACTION WAS REPORTED BY THE HEALTHCARE FACILITY.

    Description of Event or Problem · 1

    ALPHA OMEGA'S DISPOSABLE STERILE CANNULA FOR NEUROSURGERY, MODEL: TAPERED CANNULA (PN STR-000076-10) WAS USED DURING A ROUTINE PLACEMENT OF A DBS ELECTRODE NEUROSURGERY PROCEDURE. FOLLOWING THE NEUROSURGERY, THE USER COMPLAINED THAT HE NOTICED UNUSUAL HEMORRHAGE WHICH HE SUSPECTS THAT WAS CAUSED BY THE USE OF ALPHA OMEGA'S DISPOSABLE STERILE CANNULA. NO OTHER ADVERSE NEUROSURGERY OUTCOMES WERE REPORTED. NO REMEDIAL ACTION WAS REPORTED BY THE HEALTHCARE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151445 ALPHA OMEGA STERILE DISPOSABLE CANNULA GZL ALPHA OMEGA ENGINEERING LTD. TAPERED 30106 07290014954731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other