BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM

    MDR report key: 14696424 · Received June 15, 2022

    Report

    Report Number
    3006722112-2022-00052
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 18, 2022
    Report Date
    May 19, 2022
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    PKL
    PMA / PMN Number
    K201808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MEDWATCH SUBMITTED TO THE FDA ON 15/JUN/2022. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS FOR USE (IFU) ADDRESSED THE KNOWN AND POTENTIAL EVENTS OF "BLEEDING " AS FOLLOWS: WARNINGS THE DEVICE SHOULD NOT BE USED TO TREAT ACUTELY BLEEDING ULCERS, ULCERS WITH STIGMATA OF RECENT BLEEDING OR ANY ULCERS WITH A VISIBLE VESSEL. DO NOT USE A DEVICE WHERE THE INTEGRITY OF THE STERILE PACKAGING HAS BEEN COMPROMISED OR IF THE DEVICE APPEARS DAMAGED. ONLY PHYSICIANS POSSESSING SUFFICIENT SKILL AND EXPERIENCE IN SIMILAR OR THE SAME TECHNIQUES SHOULD PERFORM ENDOSCOPIC PROCEDURES. CONTACT OF ELECTROSURGICAL COMPONENTS WITH OTHER COMPONENTS MAY RESULT IN INJURY TO THE PATIENT AND/OR OPERATOR AS WELL AS DAMAGE TO THE DEVICE AND/OR ENDOSCOPE. VERIFY COMPATIBILITY OF ENDOSCOPE SIZE, ENDOSCOPIC INSTRUMENTS AND ACCESSORIES AND ENSURE PERFORMANCE IS NOT COMPROMISED. ENSURE ENDOSCOPE IS CLEAN, DRY, AND FREE OF LUBRICANTS PRIOR TO DEVICE INSTALLATION. ENSURE ALL ENDOSCOPIC SCOPES, INCLUDING SCOPE CHANNELS, ARE IN GOOD WORKING CONDITION PRIOR TO USE. SUCTION OPERATION THROUGH ENDOSCOPE MAY BE SIGNIFICANTLY REDUCED WHEN THE SCOPE CHANNEL LINER IS IN PROPER POSITION. DO NOT PUSH THROUGH OR PULL BACK ON A RETROFLEXED SCOPE WITH INSTALLED HELIX TACK. APPLYING EXCESSIVE FORCE TO THE DISTAL END OF THE X-TACK¿ DEVICE COULD COMPRESS OR DAMAGE THE HELIX TACK WHEN INSTALLED. DO NOT RETRACT DEVICE INTO SCOPE WHILST A HELIX TACK IS INSTALLED. REUSE OR REPROCESSING OF THE X-TACK¿ SYSTEM COULD RESULT IN DEVICE MALFUNCTION, PRECAUTIONS: THE SYSTEM MAY ONLY BE USED IF PURCHASED FROM APOLLO ENDOSURGERY, INC. OR ONE OF ITS AUTHORIZED AGENTS. ADVERSE EVENTS: POSSIBLE COMPLICATIONS THAT MAY RESULT FROM USING THE X-TACK¿ SYSTEM INCLUDE, BUT MAY NOT BE LIMITED TO: PHARYNGITIS / SORE THROAT, NAUSEA AND / OR VOMITING, ABDOMINAL PAIN AND / OR BLOATING, HEMORRHAGE, HEMATOMA, CONVERSION TO LAPAROSCOPIC OR OPEN PROCEDURE, STRICTURE, NFECTION / SEPSIS, PHARYNGEAL, GASTRIC, COLONIC AND/OR ESOPHAGEAL PERFORATION, ESOPHAGEAL, GASTRIC, COLONIC AND/OR PHARYNGEAL LACERATION, INTRA-ABDOMINAL (HOLLOW OR SOLID) VISCERAL INJURY, ASPIRATION, WOUND DEHISCENCE, ACUTE INFLAMMATORY TISSUE REACTION, DEATH. ADDITIONAL INFORMATION: THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE INVESTIGATOR IS WAITING UNTIL THE LOT NUMBER OF THE DEVICE IS KNOWN TO DETERMINE WHETHER A DEVICE HISTORY RECORD (DHR) REVIEW IS OR IS NOT REQUIRED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    PATIENT POST PROCEDURE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836106 X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM ENDOSCOPIC TACKING SYSTEM PKL APOLLO ENDOSURGERY, INC. XTACK-235-H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization