BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH

    MDR report key: 6992760 · Received November 1, 2017

    Report

    Report Number
    3005075853-2017-05808
    Event Type
    Injury
    Date Received
    November 1, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AUTHOR BELIEVE THAT THE POST-OPERATIVE ISSUES NOTED IN THE JOURNAL ARTICLE WERE DIRECTLY RELATED TO AN ALLEGED DEFICIENCY WITH AN ETHICON DEVICE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF JOURNAL ARTICLE: PANCREATIC THICKNESS AS A PREDICTIVE FACTOR FOR POSTOPERATIVE PANCREATIC FISTULA AFTER DISTAL PANCREATECTOMY USING AN ENDOPATH STAPLER. AUTHORS: KEIICHI OKANO, MINORU OSHIMA, KEITARO KAKINOKI, NAOKI YAMAMOTO, SHINTARO AKAMOTO, SHINICHI YACHIDA, MASANOBU HAGIIKE, HIDEKI KAMADA, TSUTOMU MASAKI, YASUYUKI SUZUKI. CITATION: SURG TODAY (2013) 43:141¿147. DOI 10.1007/S00595-012-0235-4. THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE RISK FACTORS FOR THE FORMATION OF PANCREATIC FISTULA (PF) AFTER DISTAL PANCREATECTOMY (DP) WITH A STAPLER USING A SLOW PARENCHYMAL FLATTENING TECHNIQUE. A TOTAL OF 31 PATIENTS [13 FEMALE, 18 MALE; MEAN AGE 65.5+/-2.3 (RANGE 24-82) YEARS; MEAN BMI 21.5+/-0.48 KG/M2] UNDERWENT DP WITH AN ENDOPATH STAPLER WITH A SLOW PARENCHYMAL FLATTENING TECHNIQUE BETWEEN JUNE 2006 AND DECEMBER 2010. THE PANCREAS IS TRANSECTED WITH AN ECHELON 60 STAPLING DEVICE WITH A GOLD CARTRIDGE (COMPRESSIBLE THICKNESS TO 1.8 MM). CLINICAL PF DEVELOPED IN 7 PATIENTS AFTER DP WITH A STAPLER. ONE OF THESE PATIENTS WITH SEVERE PF (ISGPF GRACE C) UNDERWENT REOPERATION. THE PATIENT HAD A HARD AND THICK PANCREAS, AND SUBSEQUENTLY EXPERIENCED PANCREATIC TISSUE CRUSHING DURING TRANSECTION WITH THE STAPLER. THE PATIENT RECOVERED AFTER NECROSECTOMY, INCLUDING DRAINAGE OF THE INFECTIOUS NECROTIC TISSUE ASSOCIATED WITH PF. A COMPARATIVE ANALYSIS OF PATIENTS WITH AND WITHOUT PF REVEALED THAT THE PANCREATA WERE SIGNIFICANTLY THICKER IN PATIENTS WITH PF (19.4+/-1.47 MM) THAN IN THOSE WITHOUT PF (12.6+/-0.79 MM; P=0.0003). STAPLE CLOSURE SEEMS TO BE SUITABLE FOR PATIENTS WITH A PANCREATIC THICKNESS OF <16 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773995 ECHELON ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention