BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 7073506 · Received November 30, 2017

    Report

    Report Number
    2027111-2017-02133
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    October 19, 2017
    Report Date
    December 13, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K083638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DEVICE HAS BEEN RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE SEAL FROM THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION, ALONG WITH A RUBBER FRAGMENT. VISUAL INSPECTION CONFIRMED THE COMPLAINANT'S EXPERIENCE OF SEAL COMPONENT SEPARATION. THE RUBBER FRAGMENT COMPLETED THE MISSING PORTION ON THE SEPTUM, A RUBBER COMPONENT OF THE SEAL. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY 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." THE RISKS ASSOCIATED WITH THIS EVENT HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. 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: LAP HEMICOLECTOMIE TRANSLATION: LAP HEMICOLECTOMY EVENT DESCRIPTION: RUBBER DOPJE WAT IN DE SEAL TROCAR ZIT WAS TIJDENS DE PROCEDURE LOSGERAAKT EN IN DE BUIKHOLTE BELAND. DOPJE UIT DE BUIKHOLTE GEHAALD EN VERDER GEGAAN MET DE DE PROCEDURE. GEBRUIKTE INSTRUMENTEN; PAKTANGEN EN STAPLER,GEEN SCHAARTJE OMDAT DANIELLE NIET BIJ DE PROCEDURE AANWEZIG WAS EN DE MELDING PAS EEN AANTAL DAGEN LATER KREEG, WIST ZIJ WIST NIET MEER WELKE 12X100 TROCAR HET WAS; DE CFF73 (HELE TROCAR), OF DE CFS22 (SLEEVE) OP HET FORMULIER HEB IK DE CFS22 INGEVULD MET MOGELIJKE LOTNUMMERS. ONDERSTAAND HET COMPLETE LIJSTJE MET MOGELIJKE LOTNUMMERS WAT ZIJ HEEFT DOORGEGEVEN. CFS22 LOT 1295752. CFS22 LOT 1297445. CTF73 LOT 1294914. TRANSLATION: THE RUBBER CAP THAT'S IN THE SEAL OF THE TROCAR DETACHED DURING THE PROCEDURE AND FELL INTO THE ABDOMINAL CAVITY. RETRIEVED THE CAP AND CONTINUED WITH THE PROCEDURE. USED INSTRUMENTS: GRASPERS AND STAPLERS, NO SCISSORS BECAUSE [NAME] WAS NOT PRESENT DURING THE PROCEDURE AND ONLY RECEIVED THE NOTIFICATION A FEW DAYS LATER, SHE DIDN'T REMEMBER WHICH 12X100 TROCAR IT WAS: CFF73 (WHOLE TROCAR) OR THE CFS22 (SLEEVE) ON THE FORM I FILLED IN THE CFS22 WITH THE POSSIBLE LOT NUMBERS. BELOW THE COMPLETE LIST WITH POSSIBLE LOT NUMBERS THAT SHE PASSED ON. TYPE OF INTERVENTION: N/A. PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850887 UNKNOWN GCJ GCJ APPLIED MEDICAL RESOURCES CFS22 OR CFF73 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1