BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 8364680 · Received February 24, 2019

    Report

    Report Number
    1219930-2019-01053
    Event Type
    Injury
    Date Received
    February 24, 2019
    Date of Event
    November 2, 2018
    Report Date
    April 11, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    (B)(4) CAUSED BY METAL STAPLES 6 YEARS AFTER THE INITIAL SURGERY SOURCE MEDICINE. 2018 97:49((B)(4)) RECEIVED 20 JULY 2018. ACCEPTED 2 NOVEMBER 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY, IT WAS REPORTED A (B)(6) YEAR OLD PATIENT UNDERWENT LAPAROSCOPIC TOTAL HYSTERECTOMY WITH THE STAPLER FOR UTERINE MYOMA 6 YEARS PRIOR IN THE UNITED STATES. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH RIGHT LOWER QUADRANT (RLQ) PAIN AND VOMITING. A COMPUTED TOMOGRAPHY (CT) REVEALED A CLOSED-LOOP OBSTRUCTION WITH VOLVULUS INVOLVING THE DISTAL ILEUM. EMERGENCY LAPAROSCOPIC SURGERY WAS PERFORMED. A FIBROUS BAND AROUND THE SURGICAL STAPLES CONSIDERED TO HAVE BEEN USED IN A PREVIOUS OPERATION WAS OBSERVED WHICH EXTENDED TO THE GREATER OMENTUM, THROUGH WHICH A SEGMENT OF THE BOWEL FORMED A CLOSED-LOOP OBSTRUCTION AROUND THE RIGHT OVARY. OUTCOMES: THE PATIENT¿S SYMPTOMS RESOLVED AND A FOLLOW-UP ON POST-OPERATIVE DAY 14 SHOWED NO SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158156 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O