BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (28MM - 4.8MM)

    MDR report key: 6080808 · Received November 4, 2016

    Report

    Report Number
    2647580-2016-00922
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 7, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GAG
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER DETAILS REGARDING PATIENT, PRODUCT OR PROCEDURE WERE PROVIDED BY THE REPORTER.

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THIS EVALUATION WAS BASED ON A MEDICAL AND TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE VISUAL INSPECTION OF THE STAPLE GUIDE NOTED THE INSTRUMENT WAS FULLY APPLIED. THE ANVIL OF THE INSTRUMENT WAS OBSERVED TO BE TILTED AND ATTACHED TO THE INSTRUMENT. A MICROSCOPE EXAMINATION OF THE DEVICE DISPLAYED NICKS ON THE KNIFE BLADE. FUNCTIONALLY, THE DEVICE WAS RELOADED WITH A FULL COMPLEMENT OF STAPLES AND APPLIED OVER THE APPROPRIATE TEST MEDIA PRODUCING ACCEPTABLE RESULTS. THE KNIFE CUT THE TEST MEDIA CLEANLY AND COMPLETELY, DESPITE THE NOTED KNIFE BLADE DAMAGE AND THE STAPLE LINE WAS PROPERLY FORMED. AS NOTED IN THE SAFETY MEDICAL ASSESSMENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A MEDICAL AND TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE VISUAL INSPECTION OF THE STAPLE GUIDE NOTED THE INSTRUMENT WAS FULLY APPLIED. THE ANVIL OF THE INSTRUMENT WAS OBSERVED TO BE TILTED AND ATTACHED TO THE INSTRUMENT. A MICROSCOPE EXAMINATION OF THE DEVICE DISPLAYED NICKS ON THE KNIFE BLADE. FUNCTIONALLY, THE DEVICE WAS RELOADED WITH A FULL COMPLEMENT OF STAPLES AND APPLIED OVER THE APPROPRIATE TEST MEDIA PRODUCING ACCEPTABLE RESULTS. THE KNIFE CUT THE TEST MEDIA CLEANLY AND COMPLETELY, DESPITE THE NOTED KNIFE BLADE DAMAGE AND THE STAPLE LINE WAS PROPERLY FORMED. AS NOTED IN THE SAFETY MEDICAL ASSESSMENT, THE DOCTOR REPORTED THAT THE STAPLE LINE WAS INTACT AND THE STAPLE FORMATION WAS ACCEPTABLE DURING THE PROCEDURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AT THAT TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER; AFTER USE OF THE DEVICE DURING A LOW ANTERIOR RESECTION PROCEDURE, A LEAK WAS DETECTED BY MEANS OF A BARIUM TEST. THE PATIENT'S COLOSTOMY HAD TO BE REOPENED IN ORDER TO ADDRESS THE ISSUE, INCREASING THE DURATION OF THE HOSPITAL STAY. THE PATIENT HAS SINCE BEEN RELEASED FROM THE HOSPITAL. ACCORDING TO THE DOCTOR, THE STAPLE LINES WERE INTACT AND THERE WAS NO ISSUE WITH THE STAPLE FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729666 EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (28MM - 4.8MM) STAPLER, SURGICAL GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA28 P6D0507KX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R