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 "bleeding, hospitalization, medication, and blood transfusion " 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.The investigator determined a device history record (dhr) review is not possible for this complaint, as the reporter noted the device lot number was unavailable.Device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.
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