BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS

    MDR report key: 18283210 · Received December 7, 2023

    Report

    Report Number
    3006722112-2020-00233
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    February 22, 2022
    Report Date
    November 6, 2023
    Manufacturer
    APOLLO ENDOSURGERY, INC
    Product Code
    OCW
    PMA / PMN Number
    K201808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINED MEDWATCH SUBMITTED TO THE FDA ON 07/DEC/2023. CLINICAL STUDY (B)(6). 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 "HOSPITALIZATION " 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, INFECTION / 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. DHR REVIEW WAS COMPLETED FOR LOT NUMBER, AF04698 (SEE (B)(6) . THE SUBJECT PRODUCT MET ALL SPECIFICATIONS AND REQUIREMENTS IN EFFECT AT THE TIME OF MANUFACTURE. THERE WAS ONE OTHER COMPLAINT IN THE APOLLO DATABASE AGAINST THIS LOT NUMBER, AF04698. DEVICE EVALUATION SUMMARY: ASSESSMENT OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT POSSIBLE. THE USER EFFECT DEFLATION IS A KNOWN AND LABELED POSSIBLE EVENT. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS WAS A COMPLAINT FROM A CLINICLA STUDY: PATIENTS SPENT 12DAY IN ICU. THE PATIENT SPENT OVER A MONTH IN THE HOSPITAL. THE PROCEDURE WAS A HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876639 X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS OCW APOLLO ENDOSURGERY, INC XTACK-160-H AF04698

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization