BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3010847 · Received March 19, 2013

    Report

    Report Number
    3005075853-2013-01285
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    December 17, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION MESSAGE FROM RISK MANAGER SUPERVISOR: PLEASE CLARIFY IF THE ADDITIONAL RESECTION OF THE COLON RESULTED IN ANY NEGATIVE OUTCOME FOR THE PATIENT? YES - COMPLICATIONS. WAS THE PATIENT¿S POST OPERATIVE CARE ALTERED AS A RESULT OF THE ADDITIONAL RESECTION OF THE COLON? YES - COMPLICATIONS. WHAT WAS THE PATIENT¿S CONDITION FOLLOWING THE PROCEDURE? INFECTION OCCURRED. HAS THE PATIENT HAD A FULL RECOVERY? THE PATIENT HAD A 30 DAY INPATIENT HOSPITAL STAY AND WAS DISCHARGED WITH HHC. THE MEDWATCH INDICATES THE DEVICE IS AVAILABLE FOR ANALYSIS. WHO SHOULD THE SHIPPER KIT BE SENT TO? AT THIS TIME, WE WILL BE HOLDING THIS DEVICE IN THE RISK MANAGEMENT DEPARTMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CLARIFY IF THE ADDITIONAL RESECTION OF THE COLON RESULTED IN ANY NEGATIVE OUTCOME FOR THE PATIENT? WAS THE PATIENT'S POST OPERATIVE CARE ALTERED AS A RESULT OF THE ADDITIONAL RESECTION OF THE COLON? WHAT WAS THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE? HAS THE PATIENT HAD A FULL RECOVERY? WILL THE DEVICE BE RETURNED? THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT. '

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113341 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1