BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITE STAR HIGH SPEED VIT CUTTER

    MDR report key: 6430698 · Received March 24, 2017

    Report

    Report Number
    2648035-2017-00557
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    February 20, 2017
    Report Date
    April 25, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MLZ
    UDI-DI
    05050474534117
    PMA / PMN Number
    K081681
    Removal / Correction Number
    2020664-04/13/17B-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: CORRECTION: PRODUCT CODE PROVIDED IN THE INITIAL REPORT WAS INCORRECT. THIS FOLLOW UP PROVIDES THE CORRECT PRODUCT CODE: MLZ. CORRECTION: COMMON DEVICE NAME PROVIDED IN THE INITIAL REPORT WAS INCORRECT. THIS FOLLOW UP PROVIDES THE CORRECT COMMON DEVICE NAME: DISPOSABLE VITRECTOMY CUTTER. CORRECTION: 510K# PROVIDED IN THE INITIAL REPORT WAS INCORRECT. THIS FOLLOW UP PROVIDES THE CORRECT 510K#: K081681. ADDITIONAL INFORMATION: ADDITIONAL: RETURNED TO MANUFACTURER ON 3/3/2017. DEVICE EVALUATION: THE DISPOSABLE VITRECTOMY CUTTERS WERE RETURNED TO THE MANUFACTURER AND A VISUAL INSPECTION WAS PERFORMED. THE RETURNED PRODUCT CONSISTED OF TWO POUCHES LABELED AS NGP0025 LOT NUMBER CA06182 GAUGE 25; HOWEVER THE DISPOSABLE VITRECTOMY CUTTER INSIDE THE POUCHES WERE GAUGE 20. BASED ON A VISUAL ANALYSIS, IT WAS CONFIRMED THAT THERE WAS MISMATCH OF THE GAUGE SIZE ON THE POUCH LABEL AND THE GAUGE SIZE MARKED ON THE VITRECTOMY CUTTER. AN EXTENDED INVESTIGATION WAS CONDUCTED AND INCLUDED A REVIEW OF COMPLAINT TRENDING, LABELING, MANUFACTURING LAYOUT, PROCEDURE REVIEW, AND THE MATERIAL DISPATCHING PROCESS FROM THE WAREHOUSE. A REVIEW OF HISTORICAL COMPLAINTS INDICATED THERE WAS ONE COMPLAINT (DESCRIBED HEREIN) IN THE LAST FIVE YEARS ASSOCIATED WITH THIS TYPE OF EVENT. BASED ON THE INVESTIGATION PERFORMED, IT WAS CONCLUDED THAT THE MOST PROBABLE CAUSE OF THE INCORRECT GAUGE SIZE VITRECTOMY CUTTERS IN THE POUCH WAS HUMAN ERROR DURING THE MATERIAL HANDLING PROCESS. TRAINING AWARENESS WAS CONDUCTED TO REINFORCE THE IMPORTANCE OF ADEQUATE LINE CLEARANCE AND RECONCILIATION STEPS AS INSTRUCTED IN THE CURRENT PROCEDURES/FORMS AS AN IMMEDIATE CORRECTION. OTHER CORRECTIVE AND PREVENTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED TO ADDRESS THIS ISSUE. ADDITIONALLY, A VOLUNTARY RECALL WAS INITIATED ON MARCH 30, 2017 BECAUSE OF THE POSSIBILITY THAT DUE TO THIS HUMAN ERROR, 20 GAUGE VITRECTOMY CUTTER MAY BE FOUND IN A 25 GAUGE PACKAGE AND A 25 GAUGE VITRECTOMY CUTTER MAY BE FOUND IN A 20 GAUGE PACKAGE. USE OF A VITRECTOMY CUTTER THAT IS A DIFFERENT SIZE THAN EXPECTED CAN LEAD TO THE NEED TO ALTER THE SURGICAL TECHNIQUE, INCLUDING CONJUNCTIVAL DISSECTION, INCISION ENLARGEMENT AND SCLERAL SUTURES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A SURGERY CENTER REPORTED MISLABELING ON TWO DISPOSABLE VITRECTOMY CUTTERS. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THEY ORDERED SIZE 25 GAUGE DISPOSABLE VITRECTOMY CUTTERS BUT UPON OPENING THE PACKAGE, THE ACTUAL VITRECTOMY CUTTER HAD SIZE 20 GAUGE ENGRAVED ON THE DEVICE. NO INDICATION OF PATIENT CONTACT. THIS IS 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213436 WHITE STAR HIGH SPEED VIT CUTTER DISPOSABLE VITRECTOMY CUTTER MLZ ABBOTT MEDICAL OPTICS NGP0025 05050474534117

    Patients

    Seq Age Sex Outcome Treatment
    1