BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE LINEAR STAPLER

    MDR report key: 6092609 · Received November 10, 2016

    Report

    Report Number
    3005075853-2016-06426
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    September 26, 2016
    Report Date
    November 3, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE TX30V DEVICE ARRIVED WITH NO APPARENT DAMAGE AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RETURNED VOID OF STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT CYCLED, FIRED, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WERE THE INDICATIONS FOR SURGERY: HEPATECTOMY. TX30V IS APPLIED FOR STAPLING HEPATIC VEIN; WHAT IS THE SURGEON¿S EXPERIENCE WITH THE TX30V DEVICE: HE HAS LOYALLY USED THE PRODUCT FOR SEVERAL YEARS; WERE ANY STAPLES SEEN IN THE SURGICAL FIELD, IF SO, WHAT WAS THEIR SHAPE: IT WAS NOT SHOWN ANY STAPLES; WAS THE PIN PLACED MANUALLY OR AUTOMATICALLY: IT IS UNKNOWN; WAS THE STAPLE LINE INSPECTED PRIOR TO VESSEL TRANSECTION: NO, IT WAS NOT. HE IS USED TO NOT INSPECTING; HOW MANY UNITS OF BLOOD WERE GIVEN: UNKNOWN; WHAT IS THE CURRENT PATIENT STATUS: STILL IN INTENSIVE-CARE UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE LOT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT IS THE SURGEON¿S EXPERIENCE WITH THE TX30V DEVICE? WERE ANY STAPLES SEEN IN THE SURGICAL FIELD? IF SO, WHAT WAS THEIR SHAPE? WAS THE PIN PLACED MANUALLY OR AUTOMATICALLY? WAS THE STAPLE LINE INSPECTED PRIOR TO VESSEL TRANSECTION? HOW MANY UNITS OF BLOOD WERE GIVEN? WHAT IS THE CURRENT PATIENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEPATECTOMY PROCEDURE, DURING SURGERY, THE USER USED THE PRODUCT FOR STAPLING THE HEPATIC VEIN. AFTER FINISHING THE FIRING, THE USER CUT THE VEIN AND RELEASED THE JAW. THE VEIN WAS NOT STAPLED AT ALL, THE PATIENT WAS IN THE EMERGENT SITUATION. THE SURGEON USED SUTURE FOR LIGATING THE VESSEL. PATIENT RECEIVED A TRANSFUSION AND IS STAYING IN THE INTENSIVE CARE UNIT. THE PATIENT IS CRITICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745592 PROXIMATE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA N4L21A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R