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

Model Number ESS-G02-160

Device Problems Failure to Align (2522); Difficult to Open or Close (2921)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an overstitch endoscopic suture system was used on an unknown date for a gastric fistual closure procedure.During the procedure, the overstitch anchor exchange was misaligned with the curved needle body.The physician had to slowly close the handle and rotate the anchor exchange catheter in order for the anchor and needle to line up, this was partially closed.They physician was able to complete the procedure.

Manufacturer Narrative

Block b3: approximated to november 1, 2023 based on the date the manufacturer became aware of the event.H6: imdf code a051104 captures the reportable event of needle shaft failure to close.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s capital of texas hwy; austin TX 78746
• Manufacturer (Section G): VIANT MEDICAL INC; 620 watson st sw; grand rapids MI 49504
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18792962
• MDR Text Key: 336512048
• Report Number: 3005099803-2024-00788
• 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
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 2023080691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Date Device Manufactured: 08/02/2023
• 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