BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLOSE

    MDR report key: 19895290 · Received August 2, 2024

    Report

    Report Number
    2647580-2024-03397
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    March 8, 2024
    Report Date
    August 2, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MÜMIN COSKUN MD, TEVFIK KIVILCIM UPRAK MD, ÖMER GÜNAL MD, AYGÜN ALIYEVA MD, AND ASIM CINGI MD. REINFORCEMENT IN LAPAROSCOPIC SLEEVE GASTRECTOMY: IS IT EFFECTIVE? SURGICAL LAPAROSCOPY, ENDOSCOPY & PERCUTANEOUS TECHNIQUES 34(3):P 290-294, JUNE 2024. DOI: 10.1 097/SLE.0000000000001283. PMID: 38736400. D10 CONCOMITANT PRODUCTS: UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU, (LOT# UNKNOWN) UNKNOWN-VLOC, UNKNOWN VLOC PRODUCT, (LOT# UNKNOWN) UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT, (LOT# UNKNOWN) 173022, 173022 ENDO CLOSE, (LOT# UNKNOWN) UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT, (LOT# UNKNOWN) UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU, (LOT# UNKNOWN). 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 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 BOTH GROUPS, TROCAR SITES 10 MM OR LARGER WERE SEALED USING AN ENDOCLOSE TROCAR SITE CLOSURE DEVICE WITH A 1.0 POLYDIOXANONE SUTURE. 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 TWO LEAKS IN THE REINFORCEMENT GROUP THAT WERE TREATED WITH SELF-EXPANDABLE METALLIC STENTS AND CT-GUIDED DRAINAGE. THERE WERE NINE LEAKS IN THE NONREINFORCEMENT GROUP. THREE PATIENTS WERE SUCCESSFULLY TREATED WITH LAPAROSCOPY, PRIMARY SUTURE OF THE LEAK SITE COMBINED WITH STENT PLACEMENT, AND DRAINAGE THE DAY AFTER SURGERY. THE OTHER SIX LEAKS WERE TREATED WITH LAPAROTOMY DRAINAGE AND STENT PLACEMENT. ONE PATIENT UNDERWENT A SECOND OPERATION FOR AN INCARCERATED TROCAR SITE HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376898 ENDO CLOSE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ US SURGICAL PUERTO RICO 173022

    Patients

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