BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURSTRING* 45 TEMP/PERM INSTR

    MDR report key: 4929404 · Received July 21, 2015

    Report

    Report Number
    2647580-2015-00531
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 3, 2015
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDJ
    PMA / PMN Number
    K901107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE PURSTRING¿ AUTO SUTURE¿ PURSE STRING DEVICE 45MM OPENED BY THE ACCOUNT. THE INITIAL VISUAL INSPECTION OF THE INSTRUMENT BY THE PMV INVESTIGATOR NOTED THAT ONE OF THE CARTRIDGES APPEARS TO HAVE BEEN DEPLOYED; THE SECOND CARTRIDGE DISPLAYS A FULL COMPLEMENT OF STAPLES. BOTH STAPLE CARTRIDGES WERE RECEIVED DISENGAGED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE OBSERVED CONDITION MAY OCCUR IF THE INSTRUMENT IS HANDLED ROUGHLY OR INCORRECTLY DURING APPLICATION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SIGMOIDECTOMY ACCORDING TO THE REPORTER: AT THE TIME OF THE PURSE STRING SUTURE, THE SURGEON GRASPED TISSUE AND SQUEEZED THE HANDLE. THEN, THE STAPLE POCKET PARTS OF JAWS WERE DETACHED. THE INAPPROPRIATELY STAPLED TISSUE WAS ADDITIONALLY RESECTED AND A NEW PRODUCT WAS USED WITHOUT A PROBLEM. SURGERY TIME WAS NOT EXTENDED BY OVER 30 MINUTES. NOTHING FELL INTO THE PATIENT'S CAVITY AND THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. THE LAST PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470946 PURSTRING* 45 TEMP/PERM INSTR DISPOSABLE SUTURING DEVICE GDJ COVIDIEN, FORMERLY USSC PUERTO RICO INC 020730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other