BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH

    MDR report key: 6959717 · Received October 18, 2017

    Report

    Report Number
    3005075853-2017-05528
    Event Type
    Injury
    Date Received
    October 18, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 10/18/2017. BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE POST-OPERATIVE ISSUES NOTED IN ARTICLE ARE RELATED TO THE ETHICON STAPLER?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF JOURNAL ARTICLE: EN BLOC STAPLER LIGATION OF THE RENAL VASCULAR PEDICLE DURING LAPAROSCOPIC NEPHRECTOMY. AUTHOR: STEPHAN BUSE, CHRISTIAN GILFRICH, JESCO PFITZENMAIER, JENS BEDKE, AXEL HAFERKAMP AND MARKUS HOHENFELLNER. CITATION: BJU INTERNATIONAL 2007;101:878-882. DOI:10.1111/J.1464-410X.2007.07371.X. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE, IN A PROSPECTIVE SERIES OF LAPAROSCOPIC NEPHRECTOMIES (LNS), THE SAFETY AND FEASIBILITY OF EN BLOC STAPLING FOR RESECTION AND OCCLUSION OF THE VASCULAR RENAL PEDICLE. BETWEEN OCTOBER 2003 AND MARCH 2006, 57 PATIENTS (34 MALE AND 23 FEMALE) WITH A MEAN AGE OF 59.8 YEARS (RANGE 10-83 YEARS) WERE ENROLLED IN THIS PROSPECTIVE STUDY. ALL PATIENTS SCHEDULED FOR ELECTIVE LN INDEPENDENT OF THE UNDERLYING PATHOLOGY WERE CONSIDERED SUITABLE FOR ENROLLMENT. A TRANSPERITONEAL APPROACH FOR LN WAS PERFORMED USING ENDOVASCULAR GIA STAPLER (ENDOPATH ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER: 45 MM STAPLE LINE, 2.5MM STAPLE LENGTH). DURING LN, THERE WAS ONE GIA-STAPLER FAILURE LEADING TO A CONVERSION TO OPEN SURGERY. IN THIS CASE, THE STAPLING DEVICE COULD NOT BE OPENED AFTER FIRING THE CARTRIDGE. CONSEQUENTLY, AN OPEN PROCEDURE WAS WARRANTED TO RECOVER THE DEVICE. THREE PATIENTS HAD TO UNDERGO REVISION FOR EITHER ACUTE BLEEDING (N=2) OR HAEMATOMA EVACUATION (N=1). IN ONE PATIENT WITH ACUTE BLEEDING, THE SOURCE COULD NOT BE ASCERTAINED. THE SECOND PATIENT DIFFUSELY BLED FROM THE RENAL PEDICLE STUMP. THE AUTHORS STATE THAT EVEN IN THE PATIENT WITH A DIFFUSELY BLEEDING PEDICULAR STUMP, IT IS IMPOSSIBLE TO INFER ANY DEFINITE CAUSAL RELATION BETWEEN THE BLEEDING AND THE EN BLOC STAMPLING. AT 3 MONTHS, ONE ASYMPTOMATIC PATIENT HAD FLUID COLLECTION IN THE LEFT RETROPERITONEUM THAT DID NOT REQUIRE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739391 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention