BEUDAMED
    FDA Adverse Event Death Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 6028474 · Received October 13, 2016

    Report

    Report Number
    1416891-2016-00007
    Event Type
    Death
    Date Received
    October 13, 2016
    Date of Event
    September 19, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ANCHOR PRODUCTS COMPANY
    Product Code
    GCJ
    PMA / PMN Number
    K091930
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS FILING THE TISSUE RETRIEVAL PRODUCT HAS NOT YET BEEN RETURNED FROM THE USER FACILITY FOR EVALUATION. THE INVESTIGATION REMAINS IN PROCESS. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON THE COMPLETION OF THE PRODUCT EVALUATION AND COMPLAINT INVESTIGATION. ON 11/1/2016 A VISUAL REVIEW OF THE COMPLAINT SAMPLE WAS PERFORMED ON SITE AT THE ACCOUNT. IT WAS OBSERVED THAT THE LEFT ARM OF THE PRODUCT WAS DAMAGED. DETERMINATION OF HOW THE DAMAGE OCCURRED HAS NOT BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    AS OF THIS FILING, (B)(6) ONLY ALLOWED MINIMAL HANDLING OF THE COMPONENTS FOR PICTURE TAKING AND NO PHYSICAL REVIEW. THE PRODUCT CODE / LOT WAS CONFIRMED AS TRS190SB2 LOT 80B4T. THE LEFT ARM (PRODUCT FACING DOWN) WAS BENT IN MULTIPLE POSITIONS. THE ARM BEND WAS NOT RELATED TO PRE-CASE EVENT. THE ARM BEND WAS RELATED TO "DURING CASE" OR "POST CASE" EVENTS. THE ARM BEND WAS NOT RELATED TO INDEPENDENT PRODUCT NORMAL USAGE. THE ABNORMAL BEND WAS RESULT OF SURGICAL CASE INFLUENCE "DURING CASE" USE OR "POST CASE". THERE WERE NO MUHC STAFF DURING THE REVIEW THAT COULD ANSWER QUESTIONS RELATED TO THE PRODUCT USAGE OR EVENTS OF THE SURGICAL CASE. ANCHOR PRODUCT COMPANY, AT THIS TIME, IS CONCLUDING THE COMPLAINT INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AS OF THIS FILING THE TISSUE RETRIEVAL PRODUCT HAS NOT YET BEEN RETURNED FROM THE USER FACILITY FOR EVALUATION. THE INVESTIGATION REMAINS IN PROCESS. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON THE COMPLETION OF THE PRODUCT EVALUATION AND COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    ON 04-OCT-2016, ANCHOR PRODUCTS COMPANY RECEIVED AN INCIDENT REPORT FORWARDED VIA E-MAIL BY (B)(6). LISTED BELOW IS THE EVENT DESCRIPTION AS STATED ON THE USER/FACILITY REPORT SUBMITTED TO (B)(6): THE VATS LOBECTOMY WAS GOING AS PLANNED. THE ANCHOR TISSUE RETRIEVAL SYSTEM WAS INSERTED TO RETRIEVE THE SPECIMEN. THE BAG WAS 15MM PART SIZE WITH A CAPACITY OF 1850ML. AS THE SPECIMEN WAS BEING REMOVED FROM THE CHEST CAVITY HEAVY BLEEDING OCCURRED. AFTER INSPECTING THE ANCHOR TISSUE RETRIEVAL DEVICE, IT WAS NOTED THAT ONE OF THE METALLIC ARMS WAS BENT OUTWARDS. THE PULMONARY ARTERY TO BE LACERATED BY THE ANCHOR TISSUES RETRIEVAL SYSTEM. REF# TRS175SB3 LOT #80B4T **ITEM IS DEPT WITH (B)(6) IN QPSP DEPT** ON 04-OCT-2016, ANCHOR PRODUCTS COMPANY RECEIVED AN INCIDENT REPORT FORWARDED VIA E-MAIL BY (B)(6).

    Description of Event or Problem · 1

    ON 04-OCT-2016, ANCHOR PRODUCTS COMPANY RECEIVED AN INCIDENT REPORT FORWARDED VIA E-MAIL BY (B)(6). LISTED BELOW IS THE EVENT DESCRIPTION AS STATED ON THE USER/FACILITY REPORT SUBMITTED TO (B)(6): THE VATS LOBECTOMY WAS GOING AS PLANNED. THE ANCHOR TISSUE RETRIEVAL SYSTEM WAS INSERTED TO RETRIEVE THE SPECIMEN. THE BAG WAS 15MM PART SIZE WITH A CAPACITY OF 1850ML. AS THE SPECIMEN WAS BEING REMOVED FROM THE CHEST CAVITY HEAVY BLEEDING OCCURRED. AFTER INSPECTING THE ANCHOR TISSUE RETRIEVAL DEVICE, IT WAS NOTED THAT ONE OF THE METALLIC ARMS WAS BENT OUTWARDS. THE PULMONARY ARTERY TO BE LACERATED BY THE ANCHOR TISSUES RETRIEVAL SYSTEM. REF# TRS175SB3 LOT #80B4T **ITEM IS DEPT WITH (B)(6) IN QPSP DEPT** ON 04-OCT-2016, ANCHOR PRODUCTS COMPANY RECEIVED AN INCIDENT REPORT FORWARDED VIA E-MAIL BY (B)(6).

    Description of Event or Problem · 1

    ON 04-OCT-2016, ANCHOR RECEIVED AN INCIDENT REPORT FORWARDED VIA E-MAIL BY (B)(4). LISTED BELOW IS THE EVENT DESCRIPTION AS STATED ON THE USER/FACILITY REPORT SUBMITTED TO CMDSNET: THE VATS LOBECTOMY WAS GOING AS PLANNED. THE ANCHOR TISSUE RETRIEVAL WAS INSERTED TO RETRIEVE THE SPECIMEN. THE BAG WAS 15MM PART SIZE WITH A CAPACITY OF 1850ML. AS THE SPECIMEN WAS BEING REMOVED FROM THE CHEST CAVITY HEAVY BLEEDING OCCURRED. AFTER INSPECTING THE ANCHOR TISSUE RETRIEVAL DEVICE, IT WAS NOTED THAT ONE OF THE METALLIC ARMS WAS BENT OUTWARDS. THE PULMONARY ARTERY TO BE LACERATED BY THE ANCHOR TISSUES RETRIEVAL SYSTEM. REF # TRS175SB3 LOT #80B4T **ITEM IS KEPT WITH (B)(6) IN QPSP DEPT** CONSEQUENSE: A CODE WAS CALLED AND EMERGENCY STAFF ARRIVED, THE SURGERY WAS CONVERTED TO THORACOTOMY AND THE PULMONARY ARTERY WAS CLAIMED AS PER THE ATTENDING SURGEON/DOCTOR. THE PATIENT WAS GIVEN 5 UNITS OF BLOOD AND CARDIAC MASSAGE WAS PERFORMED BY THE SURGEON FOR 30 MINUTES. THE PATIENT WAS DEFIBRILLATED 3 TIMES DURING THE 30 MINUTES WITH INTERNAL PADDLES SET AT 20 JOULES. AFTER ALL THESE MEASURES WERE TAKEN, THE PATIENT WAS PRONOUNCED DEAD AT 9:47. FOLLOW UP WITH THE USER FACILITY HAS BEEN CONDUCTED AND REMAINS IN PROGRESS. HOWEVER, TO DATE THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S DEMOGRAPHIC INFORMATION OF THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677820 TISSUE RETRIEVAL SYSTEM TISSUE RETRIEVAL SYSTEM GCJ ANCHOR PRODUCTS COMPANY TRS190SB2 80B4T

    Patients

    Seq Age Sex Outcome Treatment
    1 Death