BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8XX2, GELPORT 120MM

    MDR report key: 14079009 · Received April 11, 2022

    Report

    Report Number
    2027111-2022-00551
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 21, 2022
    Report Date
    July 14, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    20607915123912
    PMA / PMN Number
    K014047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC HAND ASSISTED SIGMOIDECTOMY. COMPLAINT 1 OF 2: #2022-000889 (MFR # 2027111-2022-00542). COMPLAINT 1 OF 2: #2022-000890. EVENT DESCRIPTION: "IN BOTH CASES THE GELPORT CAP AND ATTACHED ALEXIS CAME OUT OF THE INCISION WHEN THE SURGEON ATTEMPTED TO REMOVED HIS HAND THROUGH THE CAP. IN THE FIRST CASE, THIS HAPPENED TWICE. IN THE SECOND CASE, THIS HAPPENED ONCE. THERE WAS NO PATIENT INJURY, CURRENT PATIENT STATUS UNKNOWN. BOTH CASES CONTINUED WITH THE SAME DEVICE... NO OTHER INSTRUMENTS WERE BEING USED THROUGH THE GEL AT THE TIME OF THE EVENT. THE MODEL OF THE GELPORT IS C8XX2 (P/N 700314663), LOT NUMBER 1433372. NO PRODUCT IS AVAILABLE FOR RETURN. BOTH GELPORTS WERE BROUGHT IN UNDER A NO CHARGE SCRUB PO." BOTH CASES WERE A LAPAROSCOPIC HAND ASSISTED SIGMOIDECTOMY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 25MAR2022 FROM [NAME], ASSOCIATE CLINICAL SPECIALIST: THE PRODUCTS WERE DISPOSED OF BEFORE AMR WAS MADE AWARE OF THE INCIDENTS. ALERT DATE IS 21MAR2022. PRODUCTS ARE NOT AVAILABLE FOR RETURN. PATIENT STATUS: THERE WAS NO PATIENT INJURY, CURRENT PATIENT STATUS UNKNOWN. TYPE OF INTERVENTION: THE CASE CONTINUED WITH THE SAME DEVICE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC HAND ASSISTED SIGMOIDECTOMY. COMPLAINT 1 OF 2: #: (B)(4)- MFR# 2027111-2022-00542, COMPLAINT 1 OF 2: #: (B)(4)- MFR# 2027111-2022-00551. EVENT DESCRIPTION: "IN BOTH CASES THE GELPORT CAP AND ATTACHED ALEXIS CAME OUT OF THE INCISION WHEN THE SURGEON ATTEMPTED TO REMOVED HIS HAND THROUGH THE CAP. IN THE FIRST CASE, THIS HAPPENED TWICE. IN THE SECOND CASE, THIS HAPPENED ONCE. THERE WAS NO PATIENT INJURY, CURRENT PATIENT STATUS UNKNOWN. BOTH CASES CONTINUED WITH THE SAME DEVICE. NO OTHER INSTRUMENTS WERE BEING USED THROUGH THE GEL AT THE TIME OF THE EVENT. THE MODEL OF THE GELPORT IS C8XX2 (P/N: 700314663), LOT NUMBER: 1433372. NO PRODUCT IS AVAILABLE FOR RETURN. BOTH GELPORTS WERE BROUGHT IN UNDER A NO CHARGE SCRUB PO." BOTH CASES WERE A LAPAROSCOPIC HAND ASSISTED SIGMOIDECTOMY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 25MAR2022 FROM [NAME], ASSOCIATE CLINICAL SPECIALIST: THE PRODUCTS WERE DISPOSED OF BEFORE AMR WAS MADE AWARE OF THE INCIDENTS. ALERT DATE IS 21MAR2022. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 26APR2022 FROM [NAME], ASSOCIATE CLINICAL DEVELOPMENT SPECIALIST: INCISION SIZE FOR PROCEDURE WAS 8CM. PRODUCTS ARE NOT AVAILABLE FOR RETURN. PATIENT STATUS: THERE WAS NO PATIENT INJURY, CURRENT PATIENT STATUS UNKNOWN. TYPE OF INTERVENTION: THE CASE CONTINUED WITH THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145965 C8XX2, GELPORT 120MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES C8XX2 1433372 20607915123912

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown