BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 7583345 · Received June 8, 2018

    Report

    Report Number
    2027111-2018-00201
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 17, 2018
    Report Date
    July 20, 2018
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING WAS UNABLE TO BE PERFORMED AND THE COMPLAINANT'S EXPERIENCE COULD NOT BE REPLICATED OR CONFIRMED. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS. THE EXACT MODEL OF THE EVENT UNIT COULD NOT BE DETERMINED, THE POSSIBLE LOTS ARE LISTED BELOW: BRAND NAME: CTR03, 5X100 KII OPT ZTHR 6/BX, LOT #: 1315827, CATALOG #: 101138201, MANUFACTURING DATE / EXPIRATION DATE: JAN 26, 2018 / JAN 25, 2021, UDI: (B)(4), 510(K) #: K060096. BRAND NAME: CTS02, 5X100 KII SLEEVE ZTHR 12/BX, LOT #: 1318607, CATALOG #: 101208701, MANUFACTURING DATE / EXPIRATION DATE: MAR 01, 2018 / FEB 28, 2021, UDI: (B)(4), 510(K) #: K060096.

    Additional Manufacturer Narrative · 1

    THE EVENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: THIS CASE WAS A LAPAROSCOPIC APPENDECTOMY. THE SURGEON WAS [NAME]. REP STATED HE WAS NOT IN THE CASE. WAS ABLE TO DRIVE OVER TO THE FACILITY AND SPOKE TO DR. [NAME] AND HE STATED THAT DURING THE PROCEDURE HE NOTICED SOMETHING BLUE WAS LAYING ON THE APPENDIX. HE NOTICED IT WAS PIECE FROM THE TROCAR. HE BELIEVES THAT WHEN HE WAS INSERTING THE STAPLER THROUGH THE TROCAR THAT IT COULD HAVE TAKEN PIECE OF THE TROCAR WITH IT. HE TRIED TO LOOK THROUGH THE SCOPE TO SEE WHICH PORTION OF THE TROCAR IT WAS, BUT WAS UNABLE TO DO SO. HE SEQUESTERED ALL FOUR OF THE TROCARS BECAUSE HE IS UNAWARE OF WHICH TROCAR IT CAME FROM. THERE WAS NO PATIENT INJURY. IT WAS THE CANNULA THAT PARTICULATED. THE PIECE WAS ABLE TO BE REMOVED. ALL FOUR TROCARS WILL BE RETURNING BECAUSE IT IS UNKNOWN WHICH TROCAR WAS DAMAGED. TYPE OF INTERVENTION: THE PIECE WAS ABLE TO BE REMOVED. PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425587 UNKNOWN GCJ GCJ APPLIED MEDICAL RESOURCES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HARMONIC STAPLER