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

Model Number ESS-G02-SX1

Device Problem Mechanical Problem (1384)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 12/jun/2023.A review of the device labeling notes the following: risk review verbiage less last including labeling and monitoring.The current overstitch sx¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "overstitch-kink(s) in catheter" as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Caution: do not articulate endoscope without device accessories installed up to the distal end of the primary channel and secondary channel (if in use) as this may result in minor kinking of catheters.Troubleshooting: check to ensure that the sheath and actuation catheter running down the outside of the endoscope are not looped or kinked.Straighten the endoscope to the non-retroflexed position.Advance the endoscope forward and slightly pull any slack from the sheath and actuation catheter proximally until minimal resistance is felt.Grasp both the sheath and endoscope and adjust by advancing and retracting as a system.Note: ensure endcap is not dropped or otherwise damaged.Caution: if resistance is encountered when advancing the anchor exchange through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly.Warning: ensure appropriate suture slack has been created for desired suture path and pattern.Advance anchor exchange and/or manipulate endoscope to create suture slack.Warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Note: ensure suture is not tangled after removal from the cartridge.Caution: do not use when valve covers are closed as suture drag will be increased.Caution: if resistance is encountered when advancing the anchor exchange through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly.Additional information: the investigator determined that a device history record (dhr) review is not possible for this complaint, as the device serial and lot number are currently unknown.

Event Description

Healthcare professional reported one device had a kinked channel which may have resulted in the issues with insufflation.A backup device was used and also experienced issues with insufflation.The procedure was aborted.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 04/aug/2023.Additional information: the device has not been returned for analysis, and after multiple attempts to gather more information from the reporter, no additional information has been received.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM
• Type of Device: SUTURE SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; bldg b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 17108903
• MDR Text Key: 317043305
• Report Number: 3006722112-2023-00125
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020718
• UDI-Public: (01)10811955020718
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081853
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• 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