BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    MDR report key: 8833659 · Received July 26, 2019

    Report

    Report Number
    1820334-2019-01823
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 18, 2019
    Report Date
    October 25, 2019
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002355637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SUPPLIER INVESTIGATION WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. HOWEVER, A VIDEO DEMONSTRATING THE FAILURE WAS SUPPLIED BY THE CUSTOMER. THE VIDEO CONFIRMED THE NEEDLE WAS UNABLE TO PUNCTURE, BUT NO FURTHER VISUAL OR DIMENSIONAL ANALYSIS WAS ABLE TO BE COMPLETED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A DEVICE MASTER RECORD (DMR) REVIEW WAS PERFORMED, AND DEVICE DRAWINGS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES ASSOCIATED WITH THE COMPLAINT WERE IDENTIFIED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE'S DESIGN HISTORY FILES (DHF) WERE REVIEWED, AND THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT AND THE NEEDLE RAW MATERIAL LOT REVEALED NO REPORTED NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE DEVICE LOT. DUE TO THIS, THERE IS NO EVIDENCE SUGGESTING THAT NONCONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. A SUPPLIER INVESTIGATION WAS PERFORMED FOR THE RETURNED DEVICE. THE NEEDLE IS SUPPLIED TO COOK BY AN EXTERNAL SUPPLIER. THE SUPPLIER INVESTIGATION CONFIRMED THE DIFFICULT PUNCTURE, BUT FOUND NO NONCONFORMANCES RECORDED FOR THE REPORTED LOT. THE SUPPLIER COULD NOT CONFIRM THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE WITHOUT EVIDENCE OF A MANUFACTURING OR DESIGN ISSUE CONTRIBUTED TO THIS INCIDENT. 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. 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 INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET WAS USED DURING A GASTROSTOMY IN AN UNKNOWN PATIENT. THE OPERATOR REPORTED THE NEEDLE WAS "BLUNT." IT WAS FURTHER REPORTED THAT THE STOMACH "EVADES, "BECAUSE THE NEEDLE IS TOO DULL." ANCHORS WERE SUCCESSFULLY PLACED DURING THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627648 ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A 9676637 00827002355637

    Patients

    Seq Age Sex Outcome Treatment
    1