BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 14644838 · Received June 9, 2022

    Report

    Report Number
    1219930-2022-02156
    Event Type
    Death
    Date Received
    June 9, 2022
    Date of Event
    August 9, 2021
    Report Date
    June 9, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: TOTALLY LAPAROSCOPIC PANCREATICODUODENECTOMY: COMPARISON BETWEEN EARLY AND LATE PHASE OF AN INITIAL SINGLE-CENTER LEARNING CURVE SOURCE: INDIAN JOURNAL OF SURGICAL ONCOLOGY 12(4) 10.1007/S13193-021-01422-5. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC PANCREATICODUODENECTOMY (LPD) IN THE EARLY PHASES FOLLOWING IMPLEMENTATION OF LPD VS. THOSE WHO UNDERWENT LPD IN THE LATER PHASE OF THE STUDY, WHICH WAS CONDUCTED BETWEEN JANUARY 2017 AND MARCH 2020. IT WAS NOTED THAT THE GASTRIC ANTRUM WAS RESECTED WITH A 60-MM STAPLER WITH PURPLE CARTRIDGE USING A POWER HANDLE, THE FIRST JEJUNAL LOOP WAS SECTIONED WITH A 60-MM TRISTAPLE RELOAD WITH POWER HANDLE, AND A SIDE-TO-SIDE GASTROJEJUNOSTOMY WAS PERFORMED USING A 60-MM LINEAR STAPLER WITH A PURPLE CARTRIDGE WITH POWER STAPLER AND A SUTURE. THERE WERE 52 PATIENTS INCLUDED IN THE STUDY AND COMPLICATIONS INCLUDED: POST-OPERATIVE PANCREATIC FISTULA (POPF) TREATED ENDOSCOPICALLY, PERCUTANEOUSLY AND BY REOPERATION WITH RESECTION OF THE PANCREATIC STUMP, POST-PANCREATECTOMY HEMORRHAGE (PPH) TREATED WITH PERCUTANEOUS EMBOLIZATION AND RE-OPERATION LEADING TO ICU ADMISSION, DELAYED GASTRIC EMPTYING (DGE), AND INTRA-ABDOMINAL COLLECTION AND BILIARY LEAKAGE, ALSO TREATED WITH RE-OPERATION. IN ADDITION, TWO PATIENTS WITH PPH DECEASED WITHIN 90 DAYS FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054939 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Other| D| H| L