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

Model Number ESS-G02-160

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problems Suture Abrasion (2497); Patient Problem/Medical Problem (2688)

Event Date 10/01/2019

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 events of "overstitch-difficulty removing endcap" and "overstitch-encap detached from scope" as follows: position endcap: fully insert endoscope distal end through clear endcap strap loops until endoscope face touches the overhang stop feature.Use the monitor to orient the endcap as desired.Warning: if endoscope is removed, ensure endcap is secure to endoscope before next intubation.The endcap cannot be repositioned or refitted to the endoscope.Endcap detachment from endoscope: detached during use: close the needle body, remove any slack in actuation catheter and advance the overtube as far distally as possible and withdraw the endoscope and device into the overtube, maintaining tight hold of the sheath to keep the endcap flush with the endoscope.Warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.

Event Description

Health professional reported via medwatch (b)(4), "during the sixth suture, the cinch caught on the needle anchor and the end cap was dislodged from the endoscope tip and caught on gastric tissue on the right posterior wall at the site of the pouch reduction.Multiple attempts were made to remove the end cap from the stomach using argon plasma coagulation (apc), as well as the needle knife.The gastric tissue caught in the end cap device was successfully separated from the end cap with use of needle knife and removed from the patient.Abdomen was firm and distended.Patient was taken to ct-scan stat for chest/pelvic and abdomen x-rays.No free air seen on imaging.The device got "sutured" into the stomach of a patient with roux-y gastric bypass.Physician had to cut out the device with a needle knife.".

Manufacturer Narrative

Supplement #1-medwatch submitted to the fda on 25/feb/2020.Correction: initial medwatch stated that the device had not been received.The correction is noted in d10, g4, h3.Additional information: d10, h3, h6.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 8/nov/2019.A needle driver was returned with the anchor and cinch plug attached to the needle body.Visual evaluation of the remaining components of the needle driver show no discrepancies and without removing the cinch plug and anchor, the needle driver appears straight.Per engineering, most likely this failure is related to squeezing the needle driver handle during the cinch sequence allowing the needle body to make contact with the cinch plug.

• 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: 9476701
• MDR Text Key: 176755839
• Report Number: 3006722112-2019-00197
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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: 2019060942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 110