MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC., OVERSTITCH ENDOSCOPIC SUTURE SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number ESS-G02-160

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: device code (b)(6) captures the reportable event of needle shaft failure to align.

Event Description

It was reported to boston scientific corporation that an overstitch ess sx was used in the suturing of a stent post-edge procedure on (b)(6), 2023.During the procedure, the needle driver of the overstitch device was off-center and would not connect to the anchor exchange catheter.A new overstich device was used to suture in the axios and complete the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h10: investigation results: the overstitch endoscopic suture system was returned and upon microscopic analysis, the needle body was found to be straight.There were no problems found with the anchor exchange release button or the inner components of the receptacle during microscopic or physical analysis.During physical analysis, while closing the handle, the handle became stuck and would not open.The inside of the handle was opened and visually inspected and it was found that the pin was skipping on the racetrack.The reported event of needle shaft failure to align was confirmed.Analysis found the handle became stuck.Based on the information provided, the most probable cause of the reported event cannot be established due to lack of evidence.No problems were found that could have been related to the reported event during manufacturing documentation review.Based on a review of all available information, the cause of the reported event could not be determined.Block h11: upon further review, the manufacturer has reviewed all information and determined this event does not meet reporting criteria for the device in question.

Event Description

It was reported to boston scientific corporation that an overstitch ess sx was used in the suturing of a stent post-edge procedure on (b)(6) 2023.During the procedure, the needle driver of the overstitch device was off-center and would not connect to the anchor exchange catheter.A new overstich device was used to suture in the axios and complete the procedure.There were no patient complications as a result of this event.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY INC.,; 1120 s capital of texas hwy; bldg 1 suite 300; austin TX 78744
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18474745
• MDR Text Key: 333093028
• Report Number: 3005099803-2023-07079
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Lot Number: 2023100796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1