BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 19070412 · Received April 9, 2024

    Report

    Report Number
    3005075853-2024-02714
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 9, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/9/2024 D4: BATCH # UNK THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: PROPHYLACTIC ABDOMINAL DRAINAGE AFTER DISTAL PANCREATECTOMY (PANDORINA): AN INTERNATIONAL, MULTICENTRE, OPEN-LABEL, RANDOMISED CONTROLLED, NON-INFERIORITY TRIAL AUTHOR(S): EDUARD A VAN BODEGRAVEN, ET AL. CITATION: HTTPS://WWW.THELANCET.COM/JOURNALS/LANGAS/ARTICLE/PIIS2468-1253(24)00037-2/ABSTRACT THIS AIMED TO ASSESS THE NON-INFERIORITY OF A NO-DRAIN POLICY IN PATIENTS AFTER DISTAL PANCREATECTOMY. BETWEEN (B)(6) 2023, 282 PATIENTS UNDERGOING OPEN OR MINIMALLY INVASIVE ELECTIVE DISTAL PANCREATECTOMY FOR ALL INDICATIONS WERE INCLUDED IN THE STUDY. PATIENTS WERE RANDOMLY ASSIGNED TO THE NO-DRAIN GROUP (N=138 WOMEN AND 63 MEN) OR THE DRAIN GROUP (N=144 WOMEN AND 71 MEN), 7 PATIENTS IN THE NO-DRAIN GROUP RECEIVED A DRAIN INTRAOPERATIVELY. STAPLERS USED DURING THE STUDY WERE PROVIDED BY ETHICON (ENDO-SURGERY). REPORTED COMPLICATIONS INCLUDED UNSPECIFIED MAJOR MORBIDITY OR CLAVIEN¿DINDO SCORE =III (N=50), GRADE B OR C POSTOPERATIVE PANCREATIC FISTULA (N=55). IN CONCLUSION, A NO-DRAIN POLICY IS SAFE IN TERMS OF MAJOR MORBIDITY AND REDUCED THE DETECTION OF GRADE B OR C POSTOPERATIVE PANCREATIC FISTULA AND SHOULD BE THE NEW STANDARD APPROACH IN ELIGIBLE PATIENTS UNDERGOING DISTAL PANCREATECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456451 ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention