BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1023296 · Received April 1, 2008

    Report

    Report Number
    1219930-2008-00257
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    January 22, 2008
    Report Date
    March 26, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 04/01/2008. PLEASE NOTE THAT THE CLINICAL SAMPLE WAS NOT RETURNED FOR EVALUATION. REPRESENTATIVE STERILE SAMPLES FROM THE REPORTED LOTS WERE RETURNED AND THE ALLEGED FAILURE COULD NOT BE DUPLICATED AS NO ABNORMALITIES WERE OBSERVED AND THE PRODUCT PERFORMED ACCORDING TO SPECIFICATIONS. THE USER FACILITY WAS UNABLE TO IDENTIFY WHICH OF THE THREE IDENTIFIED DEVICES MAY HAVE BEEN USED DURING THE REPORTED EVENT. DEVICE CATALOG NUMBER: EEA 31, LOT: U7G28, DEVICE NAME: EEA 31MM SINGLE-USE STAPLER, EXPT. DATE: 07/31/2012, MANUFACT. DATE: 07/2007. DEVICE CATALOG NUMBER: EEA 25, LOT: U6M39R, DEVICE NAME: EEA 25MM SINGLE-USE STAPLER, EXPT. DATE: 12/31/2011, MANUFACT. DATE: 12/2006.

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: AFTER APPLYING THE DEVICE, A STAPLE LINE INSUFFICIENCY WAS NOTED. THE SIGMA WAS RESECTED AND THEN A DOUBLE STAPLING TECHNIQUE WAS PERFORMED WITH ANOTHER DEVICE OF DIFFERENT TYPE. SURGICAL TIME WAS EXTENDED ABOUT 30 MINUTES TO PERFORM THE NEW STAPLE LINE. THERE WAS NO BLEEDING OR LEAKAGE OBSERVED. NO FURTHER INFORMATION COULD BE PROVIDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS U7K99

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOW Required Intervention