BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET

    MDR report key: 10384122 · Received August 10, 2020

    Report

    Report Number
    1820334-2020-01459
    Event Type
    Injury
    Date Received
    August 10, 2020
    Report Date
    November 3, 2020
    Manufacturer
    COOK INC
    Product Code
    KGC
    PMA / PMN Number
    K170323
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION IT WAS REPORTED THAT THE PEEL AWAY SHEATH IN AN ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET SEPARATED FROM THE DILATOR WHICH CAUSED A TEAR IN THE PATIENT¿S STOMACH. THE G-TUBE WAS POPPED IN WITH FORCE TO COMPLETE THE PROCEDURE DURING A GASTROSTOMY TUBE PLACEMENT. THIS INCIDENT WAS REPORTED BY TURKEY CREEK MEDICAL CENTER, IN THE UNITED STATES. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. THEREFORE, NO PHYSICAL/VISUAL EXAMINATION OR DIMENSIONAL ANALYSIS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE ¿8. ONCE THE FINAL DILATOR IS REMOVED, INSERT THE APPROPRIATELY SIZED PEEL-AWAY INTRODUCER OVER THE WIRE GUIDE, WHILE MAINTAINING WIRE GUIDE POSITION. 9. CONFIRM ENDOSCOPICALLY OF FLUOROSCOPICALLY THAT THE DISTAL END OF THE PEEL-AWAY SHEATH IS THROUGH THE PERCUTANEOUS TRACT AND POSITIONED WITHIN THE STOMACH.¿ IN RESPONSE TO THIS INCIDENT, COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. SALES SHIPMENT SEARCH WAS COMPLETED BUT A LOT NUMBER COULD NOT BE DETERMINED. AS RELATED NONCONFORMANCES COULD NOT BE CONFIRMED, AND ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. 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

    PRODUCT CODE: KGC. INITIAL REPORTER OCCUPATION: LEAD TECHNOLOGIST. 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 UNKNOWN PATIENT REQUIRED THE USE OF AN ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET DURING PLACEMENT OF A GASTROSTOMY TUBE INTO THE STOMACH. THE OPERATOR REPORTED THAT THE "PEEL AWAY SEPARATED FROM THE DILATOR," CAUSING A TEAR IN THE STOMACH. THIS RESULTED WITH FREE AIR IN THE ABDOMEN. THE PROCEDURE WAS ABLE TO BE COMPLETED BY "POPPING THE [GASTROSTOMY TUBE] IN WITH FORCE." NO OTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852089 ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET KGC COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other