BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    MDR report key: 8347512 · Received February 18, 2019

    Report

    Report Number
    1820334-2019-00285
    Event Type
    Injury
    Date Received
    February 18, 2019
    Date of Event
    January 17, 2019
    Report Date
    April 17, 2019
    Manufacturer
    COOK INC
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B5 - DESCRIPTION OF EVENT: ADDITIONAL INFORMATION WAS RECEIVED ON 13MAR2019. IT WAS REPORTED THERE WERE TWO CASES OF INFECTION. BOTH WERE MANAGED BY LOCAL TREATMENTS. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    OCCUPATION: UNKNOWN. PMA/510(K) #: K152524. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS 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. SUFFICIENT CONTROLS ARE IN PLACE TO PREVENT THE REPORTED ADVERSE EVENT. THE LOT NUMBER WAS NOT PROVIDED, BUT A REVIEW OF ALL THE POSSIBLE LOTS PROVIDED FOUND ONE POTENTIALLY RELATED NONCONFORMANCE ACROSS FIVE POSSIBLE LOTS. TWO DEVICES WERE SCRAPPED FOR THIS NONCONFORMANCE. NONE OF THE SUBASSEMBLIES SHOWED ANY RELATED NONCONFORMACES. IT SHOULD BE NOTED THERE ARE NO OTHER COMPLAINTS REPORTED FOR ANY OF THESE LOTS. THE INSTRUCTIONS FOR USE (IFU) STATES TO ¿INFLATE THE STOMACH WITH APPROXIMATELY 500ML OF AIR THROUGH A NASOGASTRIC TUBE.¿ IT IS ALSO RECOMMENDED THE PROCEDURE IS DONE WITH ¿ENDOSCOPIC OR FLUOROSCOPIC VISUALIZATION, ADVANCE THE INTRODUCER NEEDLE THROUGH THE ANTERIOR ABDOMINAL WALL AND RAPIDLY THRUST THE NEEDLE ANOTHER 2-5 INCHES INTO THE AIR-FILLED STOMACH.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE HAVE BEEN ONE OR MORE INCIDENCES OF SKIN INFECTIONS FROM ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHORS. THE CUSTOMER STATED THAT THE "FIXATION BUTTONS ARE TOO BIG" AND "THE WIRE IS PLAITED WHICH IS LESS FLEXIBLE AND RISK OF INFECTION (SIC)." THE CUSTOMER ALSO STATED "THE HANDLING OF THE LOCKING SYSTEM IS DIFFICULT TO MANIPULATE." IT SHOULD BE NOTED THAT THE COMPLAINANT IS PROVIDING NEGATIVE FEEDBACK AND THERE IS NO ALLEGATION OF PRODUCT MALFUNCTION. ADDITIONAL INFORMATION REGARDING THE NUMBER AND SEVERITY OF THE INFECTION INCIDENCES HAS BEEN REQUESTED BUT IS CURRENTLY NOT AVAILABLE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140248 ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other