MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

Model Number ESS-G02-SX1

Device Problems Difficult to Insert (1316); Failure to Align (2522); Failure to Fire (2610)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on (b)(6) 2021.The reporter noted the device will not be returned for analysis.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "overstitch-difficulty passing anchor from exchange to needle body and overstitch-mis-aligned needle engagement;" as follows: warnings: 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.Assembly: fully depress anchor release button to release anchor.With anchor release button still fully depressed, slightly retract anchor exchange.Warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Trouble shooting: 13.1.2.Suture movement restricted: if the anchor is on the needle body, ensure the suture is not held proximally near the handle during the opening operation.Transfer the anchor to the anchor exchange.Open the needle body.Slowly retract the anchor exchange proximally and then advance the needle body distally to free the suture.

Event Description

The device malfunctioned which resulted in using a competitors device to complete the case.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX
• Manufacturer (Section G): VIANT MEDICAL; 5079 33rd street se; grand rapids MI 49512
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 11819956
• MDR Text Key: 252432678
• Report Number: 3006722112-2021-00036
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020718
• UDI-Public: 10811955020718
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K171886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-SX1
• Device Catalogue Number: ESS-G02-SX1
• Device Lot Number: 20201100111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR