MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. X-TACK ENDOSCOPIC HELIX TACKING SYSTEM; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	CNH-C01-213-L
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Apollo suture cinch- long failed upon opening the device - rep discovered upon opening, it was not used on the patient.Another of the same device was used instead to complete the procedure.

• Brand Name: X-TACK ENDOSCOPIC HELIX TACKING SYSTEM
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capital of tx hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 13257715
• Report Number: 13257715
• Device Sequence Number: 1518849
• Product Code: PKL
• UDI-Device Identifier: 10811955020756
• UDI-Public: (01)10811955020756(17)240405(10)AF04489
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021
• Report Date (Section F): 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNH-C01-213-L
• Device Catalogue Number: CNH-C01-213-L
• Device Lot Number: AF04489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/02/2021