BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 18499406 · Received January 11, 2024

    Report

    Report Number
    1717344-2024-00094
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    March 1, 2023
    Report Date
    January 11, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EL-SAYED ABOU EL-MAGD, AHMED ELGEIDIE, AMR ABBAS, YOUSSIF ELMAHDY, IBRAHEM LOTFY ABULAZM. MUCOSAL INJURY DURING LAPAROSCOPIC HELLER CARDIOMYOTOMY: RISK FACTORS AND IMPACT ON SURGICAL OUTCOMES. SURGERY TODAY (2023) 53. HTTPS://DOI.ORG/10.1007/S00595-023-02680-2. PAGES 1225¿1235. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 INVESTIGATED OUTCOMES OF MUCOSAL PERFORATION (MP) IN PATIENTS WHO UNDERWENT LAPAROSCOPIC HELLER MYOTOMY (LHM) FOR ESOPHAGEAL ACHALASIA BETWEEN JANUARY 2002 AND DECEMBER 2020. A LONG MYOTOMY WAS PERFORMED ON THE ESOPHAGEAL SIDE AND A SHORTER MYOTOMY ON THE GASTRIC SIDE USING LIGASURE OR A COMPETITOR DEVICE. THERE WERE 412 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED ACCIDENTAL MUCOSAL PERFORATION IN 52 PATIENTS AND AN ABSCESS IN ONE PATIENT. THE CAUSE OF MUCOSAL PERFORATION WAS EITHER MECHANICAL OR THERMAL. MOST CASES OF MUCOSAL PERFORATION WERE DETECTED INTRAOPERATIVELY AND REPAIRED LAPAROSCOPICALLY WITH SUTURE OR REQUIRED CONVERSION TO OPEN SURGERY. THREE CASES WERE DETECTED POSTOPERATIVELY, PROBABLY DUE TO A MISSED THERMAL INJURY AND REQUIRED SURGICAL REPAIR. ABSCESS WAS TREATED BY TUBE DRAINAGE AND ANTIBIOTICS. EXTENDED HOSPITALIZATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004283 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other| R| H