BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 12245353 · Received July 29, 2021

    Report

    Report Number
    3005075853-2021-04229
    Event Type
    Death
    Date Received
    July 29, 2021
    Date of Event
    January 1, 2021
    Report Date
    July 2, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/9/2021. H1: MDR DECISION: NOT REPORTABLE. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE TO INCLUDE PATIENT MORTALITY? NOT RELATED TO PRODUCT H1: MDR DECISION: NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT-ONLY EVENT YEAR KNOWN: 2021; CAPTURED AS CITATION DATE. BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE TO INCLUDE PATIENT MORTALITY? 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 · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: USE OF REINFORCED STAPLERS DECREASES THE RATE OF POSTOPERATIVE PANCREATIC FISTULA COMPARED TO BARE STAPLERS AFTER MINIMALLY INVASIVE DISTAL PANCREATECTOMIES. AUTHORS: BRIAN K.P. GOH, MBBS, MMED, MSC, FRCSED, CHUAN-YAW LEE, MBBS, YE-XIN KOH, MBBS, MMED, FRCS, JIN-YAO TEO, MBBS, MMED, FRCS, JUINN-HUAR KAM, MBBS, MMED, FRCS, PENG-CHUNG CHEOW, MBBS, FRCS, ALEXANDER Y.F. CHUNG, MBBS, FRCS, CHUNG-YIP CHAN, MBBS, MMED, MD, FRCS, AND SER-YEE LEE, MBBS, MSC, FRCS. CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES VOLUME 00, NUMBER 00, 2021. DOI: 10.1089/LAP.2020.0754. THIS RETROSPECTIVE REVIEW AIMS TO COMPARE THE OUTCOMES OF MINIMALLY INVASIVE DISTAL PANCREATECTOMY (MIDP)PERFORMED WITH REINFORCED STAPLER (RS) VERSUS BARE STAPLER (BS) WITH PARTICULAR ATTENTION TO THE POSTOPERATIVE PANCREATIC FISTULA (POPF). BETWEEN 2014 AND 2019, THERE WERE 25 AND 65 PATIENTS WHO UNDERWENT MIDP WITH RS AND BS, RESPECTIVELY USING AN ECHELON LAPAROSCOPIC STAPLER (ETHICON). THERE WERE 38 MALES AND 52 FEMALES. (N=30) POSTOPERATIVE MORBIDITY, (N=15) MAJOR MORBIDITY, (N=17) GRADE B/C PANCREATIC FISTULA, (N=1) REOPERATION, (N=2) 90-DAY MORTALITY, (N=19) READMISSION. MIDP PERFORMED WITH RS WAS ASSOCIATED WITH A SIGNIFICANTLY LOWER RATE OF POPF, MAJOR MORBIDITY, AND READMISSIONS COMPARED TO BS. THE USE OF RS WAS PROTECTIVE AGAINST POPF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145507 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death