BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPSAC TISSUE ENTRAPMENT POUCH

    MDR report key: 9882460 · Received March 26, 2020

    Report

    Report Number
    1820334-2020-00687
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 12, 2020
    Report Date
    May 5, 2020
    Manufacturer
    COOK INC
    Product Code
    KGY
    PMA / PMN Number
    K910914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION EVALUATION. (B)(6) HOSPITAL INFORMED COOK ON 12MAR2020 OF AN INCIDENT INVOLVING A LAPSAC TISSUE ENTRAPMENT POUCH (J-LS-081000). AS REPORTED, PRIOR TO USE, WHITE FOREIGN MATTER WAS FOUND ON THE COMPLAINT DEVICE. NO ADVERSE EFFECTS WERE REPORTED. A REVIEW OF THE QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE TO A LACK OF LOT INFORMATION FROM THE USER FACILITY. THERE IS NO EVIDENCE TO SUGGEST THIS DEVICE WAS MANUFACTURED OUT OF SPECIFICATION OR THAT NON-CONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE WAS NOT ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    OCCUPATION: BUYER. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAPSAC TISSUE ENTRAPMENT POUCH WAS RECEIVED AT THE HOSPITAL FACILITY WITH WHITE PAINT/WHITE-OUT ON THE PRODUCT. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346194 LAPSAC TISSUE ENTRAPMENT POUCH KGY BAG, INTESTINE KGY COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1