BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTACK 5MM INSTRUMENT

    MDR report key: 3767478 · Received April 17, 2014

    Report

    Report Number
    2647580-2014-00290
    Event Type
    Injury
    Date Received
    April 17, 2014
    Report Date
    March 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    PMA / PMN Number
    K090470
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROTOMY. ACCORDING TO THE REPORTER: IN AN ARTICLE TITLED "SMALL BOWEL LESION DUE TO SPIRAL TACKS AFTER LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH REPAIR FOR INCISIONAL HERNIA", INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS. FOUR (3) (PP 283-285), 2013. DATE OF PUBLICATION: 2013 BY HALTMEIER T. GROEBLI Y. IT IS STATED THAT A (B)(6) MALE UNDERWENT LAPAROSCOPIC INTRAPERITONEAL ONLY MESH REPAIR FOR AN INCISIONAL HERNIA 1 YEAR S/P OPEN SIGMOID RESECTION FOR PERFORATED SIGMOID DIVERTICULITIS. THE MESH HAD BEEN SECURED WITH A PROTACK DEVICE. FOUR YEARS LATER, HE UNDERWENT AN ELECTIVE OPEN CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS. THE PREOPERATIVE ABDOMINAL CT SCAN SHOWED METAL SPIRAL TACKS IN PROXIMITY TO THE SMALL BOWEL. DURING THE OPEN CHOLECYSTECTOMY, WHILE PERFORMING THE ADHESIOLYSIS, AN INCIDENTAL FINDING OF TWO TITANIUM SPIRAL TACKS ADHERENT TO THE SMALL BOWEL WERE ENCOUNTERED. THE TACKS WERE COMPLETELY INTEGRATED IN THE SEROMUSCULAR LAYER OF THE SMALL BOWEL. THE TACKS WERE REMOVED TO AVOID FUTURE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236376 PROTACK 5MM INSTRUMENT DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention