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

Model Number ESS-G02-SX1

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 29/jun/2021.Additional information: this event has been previously reported by northern light eastern maine medical center as uf/lmporter report# (b)(4).A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system directions for use (dfu) addresses the known and anticipated potential events of "kink in catheter" and 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.Caution: do not depress helix handle button while advancing helix through endoscope.The labeling is adequate as it addresses the reported complaint.

Event Description

Device malfunction.

Event Description

The overstitch port at the end of surgery was found bent.Surgery was completed successfully with a backup device.

Manufacturer Narrative

Supplement #x medwatch submitted to the fda on.The device has not been returned for analysis.A device history record (dhr) review was conducted for reporting purposes.The subject product met all specifications and requirements in effect at the time of manufacture.There were no other complaints in the apollo database against this lot number, 2020120816.

• 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
• MDR Report Key: 12084685
• MDR Text Key: 259205887
• Report Number: 3006722112-2021-00044
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• PMA/PMN Number: K181141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• 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: 2020120816
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 81