BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6041187 · Received October 19, 2016

    Report

    Report Number
    1644019-2016-01329
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    October 3, 2016
    Report Date
    February 20, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    TWO OPENED TROCAR CANNULA/HUB ASSEMBLIES WERE RECEIVED IN A TRAY FOR EVALUATION. ONE OF THE CANNULA/HUB ASSEMBLIES WAS RETURNED SEPARATED. THE RETURNED SAMPLES WERE VISUALLY INSPECTED. ONE SAMPLE WAS FOUND CONFORMING; THE CANNULA AND THE HUB WERE TOGETHER. THE SECOND SAMPLE WAS FOUND NON-CONFORMING; THE HUB AND CANNULA WERE SEPARATE. THERE WAS NO ADHESIVE PRESENT ON THE HUB OF THE SECOND SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE EVALUATION OF THE RETURNED NON-CONFORMING SAMPLE DID NOT VERIFY THE PRESENCE OF ADHESIVE INSIDE OF THE HUB. DURING ASSEMBLY OF THE TROCAR PRODUCT ADHESIVE IS DISPENSED AT THE CANNULA HUB INTERFACE. THE MOST LIKELY ROOT CAUSE OF THIS COMPLAINT IS INSUFFICIENT ADHESIVE APPLICATION DURING MANUFACTURING. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS REPORTS OF A SIMILAR NATURE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE TROCAR CANNULA BROKE DURING A LEFT EYE VITRECTOMY PROCEDURE. "THE METAL PART OF THE TROCAR DETACHED FROM THE GREEN PART, AND THE METAL PART REMAINED IN THE PATIENT¿S EYE." A SCLEROTOMY WAS PERFORMED TO REMOVE BROKEN METAL PART. THE TROCAR WAS REPLACED WITH NEW ONE. THERE PATIENT IMPROVING. A PRODUCT SAMPLE HAS BEEN REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691380 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1875884H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R TROCAR CANNULA