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

Model Number ESS-G02-160

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

Apollo has not received the product at this time.Therefore no analysis or testing has been done.A review of the device labeling notes the following: the current overstitch sx¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "overstitch-bent needle body" as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Ensure that there is sufficient space for the needle to open.Confirm both ends of the needle body are visible on the monitor.Warning: do not introduce the device with the needle body in its open position.

Event Description

Reported complaint: "needle displacement & unable to introduce endoscope in overtube".

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 18/dec/2019.The device was returned to the apollo device analysis laboratory on (b)(6) 2019.Analysis of the device is ongoing.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 9476682
• MDR Text Key: 176758179
• Report Number: 3006722112-2019-00176
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: 10811955020664
• Combination Product (y/n): N
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• 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 Catalogue Number: ESS-G02-160
• Device Lot Number: 2019030365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 118