BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 12532763 · Received September 27, 2021

    Report

    Report Number
    1717344-2021-01312
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    October 3, 2020
    Report Date
    September 27, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: LAPAROSCOPY ALLOWS THE HARVEST OF THE DIEP FLAP WITH SHORTER FASCIAL INCISIONS AS COMPARED TO ENDOSCOPIC HARVEST: A SINGLE SURGEON RETROSPECTIVE COHORT STUDY SOURCE: JOURNAL OF PLASTIC, RECONSTRUCTIVE <(>&<)> AESTHETIC SURGERY (2021) 74, 1203-1212. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED OUTCOMES OF TECHNIQUES USED TO HARVEST DEEP INFERIOR EPIGASTRIC VESSELS FOR BREAST RECONSTRUCTION BETWEEN SEPTEMBER 2017 AND APRIL 2019. THE TECHNIQUES INCLUDED: ENDOSCOPIC, TOTAL EXTRAPERITONEAL LAPAROSCOPIC, AND TRANSABDOMINAL PREPERITONEAL ROBOTIC PERFORATOR HARVEST. LIGASURE WAS USED IN 38 PATIENTS WHO UNDERWENT THE LAPAROSCOPIC TECHNIQUE. COMPLICATIONS INCLUDED: 2 PERFORATOR/PEDICLE INJURIES DUE TO TRANSECTION THAT REQUIRED ANASTOMOSIS TO SALVAGE THE GRAFT. COMPLICATIONS RELATED TO THE BREAST, THE ENDOSCOPIC TECHNIQUE, THE ROBOTIC TECHNIQUE AND DELAYED WOUND HEALING WERE NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432085 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other