BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C0R50, 12X130 KII BALLOON BLNT TIP 6/BX

    MDR report key: 6596121 · Received May 26, 2017

    Report

    Report Number
    2027111-2017-01820
    Event Type
    Malfunction
    Date Received
    May 26, 2017
    Date of Event
    March 22, 2017
    Report Date
    June 8, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915116460
    PMA / PMN Number
    13
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS RECEIVED THE INCIDENT DEVICE AND THE PRODUCT HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EVENT PRODUCT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION ALONG WITH A RUBBER FRAGMENT. UPON INSPECTION, ENGINEERING NOTED FRAGMENTATION OF AN INTERNAL RUBBER COMPONENT OF THE SEAL. 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.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED - UNKNOWN. "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO.(B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." REPORT FROM THE SALES REP "THE CUSTOMER NOTED THAT THE DDB WAS PARTIALLY DAMAGED AND A PORTION(APPROX. 1CM SQUARE) OF THE DDB WAS ATTACHED TO BE INSIDE THE SEAL. THE CUSTOMER GUESSED THAT INSERTION OF INSTRUMENTS CAUSED THE INCIDENT. SEPTUM CER CHECK LIST IS UNAVAILABLE." INITIAL INVESTIGATION REPORT BY (B)(4): "THE EVENT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE REPORTED DAMAGE TO THE DDB WAS CONFIRMED; THE DDB WAS MISSING A PORTION; THE MISSING SIZE IS APPROX. 8.1 MM X 6.9 MM. ANY PORTIONS OF THE DDB WERE NOT SENT TO OLYMPUS. NO DAMAGE WAS OBSERVED WITH THE SEPTUM AND SHIELD. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN#(B)(4)." APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION FROM THE DISTRIBUTOR VIA EMAIL ON MAY 8,2017: THE SECTION OF THE DOUBLE DUCKBILL DID NOT FALL INTO THE PATIENT IT STAYED IT STAYED WITHIN THE SEAL HOUSING. THE DISTRIBUTOR DID NOT KNOW WHAT INSTRUMENTS WERE USED IN THIS PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375234 C0R50, 12X130 KII BALLOON BLNT TIP 6/BX GCJ GCJ APPLIED MEDICAL RESOURCES 13 1282992 00607915116460

    Patients

    Seq Age Sex Outcome Treatment
    1