BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 19894179 · Received August 2, 2024

    Report

    Report Number
    1717344-2024-01573
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    March 8, 2024
    Report Date
    August 2, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN ENDO GIA SULU (LOT#: UNKNOWN); UNKNOWN VLOC PRODUCT (LOT#: UNKNOWN); 173022 ENDO CLOSE (LOT#: UNKNOWN); UNKNOWN LIGASURE INSTRUMENT (LOT#: UNKNOWN); UNKNOWN ENDO GIA SULU (LOT#: UNKNOWN) MÜMIN COSKUN, TEVFIK KIVILCIM UPRAK, ÖMER GÜNAL, AYGÜN ALIYEVA, AND ASIM CINGI. REINFORCEMENT IN LAPAROSCOPIC SLEEVE GASTRECTOMY: IS IT EFFECTIVE? SURGICAL LAPAROSCOPY, ENDOSCOPY & PERCUTANEOUS TECHNIQUES 34(3), JUNE 2024. DOI: 10.1097/SLE.0000000000001283. PMID: 38736400. PAGES 290-294. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EXAMINED STAPLER LINE REINFORCEMENT AND ITS ASSOCIATION WITH POSTOPERATIVE LEAKAGE AND BLEEDING RATES IN 510 PATIENTS WHO UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY BETWEEN 2011 AND 2018. THERE WERE 286 PATIENTS IN THE REINFORCEMENT GROUP AND 224 IN THE NONREINFORCEMENT GROUP. IN ALL PATIENTS, A LIGASURE OR A COMPETITOR DEVICE WERE USED TO PERFORM DISSECTION ALONG THE GREATER CURVATURE WAS USED STARTED 3 TO 4 CM FROM THE PYLORUS AND PROCEEDED TOWARD THE LEFT CRUS. LEAKS WERE DIAGNOSED USING COMPUTED TOMOGRAPHY (CT) OR AN UPPER GASTROINTESTINAL RADIOGRAPH. POSTOPERATIVE COMPLICATIONS INCLUDED STAPLE LINE LEAKS, BLEEDING, AND TROCAR SITE HERNIA. THERE WERE 9 LEAKS IN THE NONREINFORCEMENT GROUP. 3 PATIENTS WERE SUCCESSFULLY TREATED WITH LAPAROSCOPY, PRIMARY SUTURE OF THE LEAK SITE COMBINED WITH SEMS PLACEMENT, AND DRAINAGE THE DAY AFTER SURGERY. THE OTHER 6 LEAKS WERE TREATED WITH LAPAROTOMY DRAINAGE AND SEMS. FOUR 4 PATIENTS WHO SUFFERED BLEEDING IN NONREINFORCEMENT GROUP. TWO NEEDED EXPLORATORY LAPAROSCOPIES, THROUGH WHICH THE STAPLE LINE BLEEDING WAS FOUND AND CONTROLLED, WHEREAS 2 PATIENTS WERE TREATED CONSERVATIVELY. THERE WERE 2 LEAKS IN THE REINFORCEMENT GROUP OBSERVED 7 AND 8 DAYS AFTER THE OPERATIONS. THE LEAKS IN THE REINFORCEMENT GROUP WERE SUCCESSFULLY TREATED WITH SELF-EXPANDABLE METALLIC STENTS (SEMS) AND CT-GUIDED DRAINAGE. POSTOPERATIVE BLEEDING WAS OBSERVED IN 5 PATIENTS IN THE REINFORCEMENT GROUP AND TREATED CONSERVATIVELY. TWO PATIENTS UNDERWENT SECOND OPERATIONS: ONE FOR AN INCARCERATED TROCAR SITE HERNIA AND ANOTHER FOR A PARTIAL MIGRATION OF THE SLEEVE SEGMENT TO THE THORAX CAVITY, WHICH LED TO PARTIAL OBSTRUCTION. EXTENDED HOSPITAL STAY AND READMISSIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884467 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other| H| R