BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAUZE, XRAY, RFD, 4X4, 16-PLY, NSTRL, LF, DISP

    MDR report key: 5701581 · Received June 6, 2016

    Report

    Report Number
    3005883396-2016-00034
    Event Type
    Malfunction
    Date Received
    June 6, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 16, 2016
    Manufacturer
    RF SURGICAL
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE # : (B)(4). DATE OF INITIAL REPORT : (B)(6) 2016. TO DATE THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. A REVIEW OF THE MANUFACTURING NON CONFORMANCES WAS COMPLETED AND INDICATES ALL PARAMETERS AND ACCEPTANCE CRITERIA FOR ENTRIES POTENTIALLY PERTINENT TO THE CUSTOMER REPORT WERE WITHIN SPECIFIED LIMITS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE # : (B)(4). DATE OF INITIAL REPORT : 6 JUNE 2016. DATE OF FOLLOW-UP REPORT : 29 AUG 2016. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED SAMPLE MET SPECIFICATION. THE INVESTIGATION CONFIRMED THE PRODUCT IS LINTING. THE PRODUCT IS NOT A LINT-FREE PRODUCT. THE COTTON COMPLIES WITH USP TYPE VII STANDARDS. THE INVESTIGATION FOUND THE ROOT CAUSE OF THE REPORTED CONDITION TO BE A NORMAL RESULT OF HANDLING AND USE OF THE PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GAUZE IN THE BASIC CUSTOM PACK ARE SHEDDING AND LEAVING REMNANTS IN THE PATIENT. UNSURE WHICH OF THE FOLLOWING BASIC CUSTOM PACK THIS IS FROM: STERILE KP STD BASIC PACK SHEET EXP DATE: (B)(6) 2020, MFT DATE: (B)(6) 2016, LOT# 516602, 508390, 511933 , CATALOG KA13BBPKPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357056 GAUZE, XRAY, RFD, 4X4, 16-PLY, NSTRL, LF, DISP RF DETECT GAUZE GDY RF SURGICAL 160102A

    Patients

    Seq Age Sex Outcome Treatment
    1