BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX

    MDR report key: 6641564 · Received June 14, 2017

    Report

    Report Number
    2027111-2017-01827
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    February 9, 2017
    Report Date
    July 11, 2017
    Manufacturer
    TOKYO METROPOLITAN BOKUTOH HOSPITAL /OLY
    Product Code
    GCJ
    UDI-DI
    00607915116453
    PMA / PMN Number
    4
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT PRODUCT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. THE RUBBER FRAGMENT RETURNED MATCHED THE MISSING PORTION ON THE SEAL. THE LIKELY ROOT CAUSE OF THE DAMAGE TO THE SEAL IS AN INSTRUMENT. APPLIED MEDICAL'S INSTRUCTIONS FOR USE STATES THAT "EXTRA CARE SHOULD BE USED WHEN INSERTING ANGULAR AND ASYMMETRICAL INSTRUMENTS, SUCH AS 'J' HOOKS AND CLIP APPLIERS. ALL INSTRUMENTS SHOULD BE CENTERED AXIALLY WHEN INSERTED THROUGH THE SEAL TO PREVENT TEARING." 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.

    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 RECTECTOMY. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO.(B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. REPORT FROM THE SALES REP: A FRAGMENT OF THE RUBBER COMPONENT INSIDE THE SEAL FELL OFF INSIDE THE PATIENT CAVITY. THE RUBBER COMPONENT INSIDE THE SEAL WAS DISMANTLED TO INSPECT BY THE FACILITY. INITIAL INVESTIGATION REPORT BY (B)(4): THE SEPTUM, THE DDB, THE SHIELD AND ONE(1) RUBBER FRAGMENT WERE RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE RUBBER FRAGMENT SIZE IS APPROX..3.0MM X 3.8MM. THE FRAGMENT MATCHED A MISSING PORTION ON THE SEPTUM. THE UNIT WILL BE RETURNED TO (B)(4) FOR FURTHER EVALUATION. ADMIN#(B)(4). TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422683 C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX GCJ GCJ TOKYO METROPOLITAN BOKUTOH HOSPITAL /OLY 4 1276720 00607915116453

    Patients

    Seq Age Sex Outcome Treatment
    1