BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 7862417 · Received September 10, 2018

    Report

    Report Number
    2027111-2018-00347
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Report Date
    November 13, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE 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.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: UNKNOWN. CER 1 OF 5: (B)(4), CER 2 OF 5: (B)(4), CER 3 OF 5: (B)(4), CER 4 OF 5: (B)(4), CER 5 OF 5: (B)(4). THE ALEXIS CES TEAM MET WITH TEAM MEMBER YESTERDAY AND WE MENTIONED WE RECEIVE FEEDBACK THAT THE GUARD PROVIDED IN THE ALEXIS CONTAINED EXTRACTION KITS POPS OUT OF THE INCISION WHEN MORCELLATING IN HIGHER BMI PATIENTS. IN THESE CASES, THE GUARD DOESN'T BREAK AND CAN BE REINSERTED INTO THE INCISION THOUGH SURGEONS MAY NOT REPLACE IT IF THEY FEEL COMFORTABLE WITH THEIR MORCELLATING TECHNIQUE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 13AUG2018 FROM APPLIED MEDICAL CLINICAL DEVELOPMENT. IT WAS PREVIOUSLY MENTIONED THAT SIMILAR INCIDENTS OCCURRED UP TO 10 TIMES. THIS WAS AN ESTIMATE. I WAS CALLING FIELD TEAM MEMBERS AND ASKING SURGEONS WHO VISITED FOR GUARD FEEDBACK THAT WE SHOULD TAKE INTO CONSIDERATION FOR DESIGN ENHANCEMENTS. ONCE I HEARD THIS FEEDBACK I STARTED DIRECTLY ASKING IN CALLS/VISITS IF THE GUARD HAD EVER DISLODGED FROM THE INCISION. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 17AUG2018 FROM APPLIED MEDICAL CLINICAL DEVELOPMENT. I READ BACK OVER MY NOTES AND THINK WE SHOULD CREATE AN ADDITIONAL CER FOR GUARD FEEDBACK. THIS WOULD MAKE IT 5 CERS TOTAL. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 31AUG2018 FROM APPLIED MEDICAL CLINICAL DEVELOPMENT. THE ARE TWO KNOWN HOSPITALS/ACCOUNTS WERE THE DOCTORS PRACTICE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 04SEP2018 FROM APPLIED MEDICAL CLINICAL DEVELOPMENT. NO I DO NOT KNOW IF THEY WERE USING GTB14 OR GTB17 AT THE TIME OF THE INCIDENTS. THE ACCOUNTS LISTED WERE THE ACCOUNTS THE DOCTORS LISTED AS THEIR MAIN PRACTICING FACILITY FOR THE SURGEON VISIT. I DO NOT KNOW WHAT FACILITY THE INCIDENT ACTUALLY TOOK PLACE OR THE DATE THEY OCCURRED. THE DATE I PROVIDED ORIGINALLY WAS THE DATE THE DOCTORS VISITED RSM. PATIENT STATUS: UNKNOWN. TYPE OF INTERVENTION: UNKNOWN.

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

    Description of Event or Problem · 1

    CER 1 OF 5: 2018-1291, CER 2 OF 5: 2018-100248, CER 3 OF 5: 2018-100249, CER 4 OF 5: 2018-100252, CER 5 OF 5: 2018-100266. THE ALEXIS CES TEAM MET WITH TEAM MEMBER YESTERDAY AND WE MENTIONED WE RECEIVE FEEDBACK THAT THE GUARD PROVIDED IN THE ALEXIS CONTAINED EXTRACTION KITS POPS OUT OF THE INCISION WHEN MORCELLATING IN HIGHER BMI PATIENTS. IN THESE CASES, THE GUARD DOESN'T BREAK AND CAN BE REINSERTED INTO THE INCISION THOUGH SURGEONS MAY NOT REPLACE IT IF THEY FEEL COMFORTABLE WITH THEIR MORCELLATING TECHNIQUE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2018 FROM APPLIED MEDICAL CLINICAL DEVELOPMENT. IT WAS PREVIOUSLY MENTIONED THAT SIMILAR INCIDENTS OCCURRED UP TO 10 TIMES. THIS WAS AN ESTIMATE. I WAS CALLING FIELD TEAM MEMBERS AND ASKING SURGEONS WHO VISITED FOR GUARD FEEDBACK THAT WE SHOULD TAKE INTO CONSIDERATION FOR DESIGN ENHANCEMENTS. ONCE I HEARD THIS FEEDBACK I STARTED DIRECTLY ASKING IN CALLS/VISITS IF THE GUARD HAD EVER DISLODGED FROM THE INCISION. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2018 FROM APPLIED MEDICAL CLINICAL DEVELOPMENT. I READ BACK OVER MY NOTES AND THINK WE SHOULD CREATE AN ADDITIONAL CER FOR GUARD FEEDBACK. THIS WOULD MAKE IT 5 CERS TOTAL. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2018 FROM APPLIED MEDICAL CLINICAL DEVELOPMENT. THE ARE TWO KNOWN HOSPITALS/ACCOUNTS WERE THE DOCTORS PRACTICE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2018 FROM APPLIED MEDICAL CLINICAL DEVELOPMENT NO I DO NOT KNOW IF THEY WERE USING GTB14 OR GTB17 AT THE TIME OF THE INCIDENTS. THE ACCOUNTS LISTED WERE THE ACCOUNTS THE DOCTORS LISTED AS THEIR MAIN PRACTICING FACILITY FOR THE SURGEON VISIT. I DO NOT KNOW WHAT FACILITY THE INCIDENT ACTUALLY TOOK PLACE OR THE DATE THEY OCCURRED. THE DATE I PROVIDED ORIGINALLY WAS THE DATE THE DOCTORS VISITED RSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701971 UNK UNK GCJ APPLIED MEDICAL RESOURCES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1