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

Model Number ESS-G02-SX1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Liver Damage/Dysfunction (1954); Pancreatitis (4481); Unspecified Kidney or Urinary Problem (4503)

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 26/may/2023.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-endcap strap breakage/slippage" as follows: secure endcap straps: the strap appears clear in color when sufficiently tightened.Warning: straps should not be stretched beyond 3cm (1 inch) of travel as damage may occur.Warning: confirm the concealed ends of both endcap straps are fully recessed within the endcap.Warnings: only physicians possessing sufficient skill and experience in similar, or the same techniques should perform endoscopic procedures.Possible complications that may result from using the endoscopic suturing system include, but may not be limited to: pharyngitis / sore throat.Nausea and / or vomiting.Abdominal pain and / or bloating.Hemorrhage.Hematoma.Conversion to laparoscopic or open procedure.Stricture.Infection / sepsis.Pharyngeal, colonic and/or esophageal perforation.Esophageal, colonic and/or pharyngeal laceration.Intra-abdominal (hollow or solid) visceral injury aspiration.Wound dehiscence.Acute inflammatory tissue reaction.Death.Additional information: the device has not been returned for analysis.Dhr review was completed for lot number, 2023010305.The subject product met all specifications and requirements in effect at the time of manufacture.There was two other complaint in the apollo database against this lot number 2023010305, and allegation.

Event Description

Device fell off scope - sticky tabs not adhering.On 25/may/2023 additional information: stent placed, boston sci clips placed to secure in lieu of endostitch and found out that the patient passed away due to a chronic condition.

Manufacturer Narrative

Supplement 01 medwatch submitted to the fda on 20/jun/2023.Additional information: a dhr review was completed for lot number, 2023010305.The subject product met all specifications and requirements in effect at the time of manufacture.There was two other complaint in the apollo database against this lot number 2023010305, and allegation.Device evaluation summary: the devices were returned to the apollo device analysis laboratory on 05/june/2023.A needle driver and anchor exchange was received for evaluation.The suture is in the channel and there is a cinch plug on the distal end.The returned anchor exchange was used to remove the anchor from the needle body for functional testing.Under microscopic analysis, the needle body is straight.An inspection pin was installed onto the anchor exchange channel of the endcap.When the handle was depressed, the needle body tip entered the inspection pin hole without bending or flexing.The sample suture anchor was loaded into the anchor exchange, and the exchange was advanced into the endcap holder.When the needle driver was actuated, the anchor engaged to the needle body.This test was successfully repeated several times.The anchor exchange release button was within the appropriate travel distance of the release handle.Under microscopic analysis, the inside of the receptacle was observed while pressing the release button.The latch, hard stop, and opener were all observed; the opener passed under the latch while advancing towards the distal end of the receptacle.The sample anchor was inserted into the receptacle for testing; when the release button was pressed, the anchor released.A tube was used to test the straps by wrapping them around the channel and the straps did not hold.An attempt was made to wipe down the straps; however, they would not adhere to the channel when tested a second time.The complaint has been verified as during functional evaluation; the straps would not adhere to the channel.On 25/may/2023 additional information: - stent placed, boston sci clips placed to secure in lieu of endostitch and found out that the patient passed away due to a chronic condition.

• Brand Name: OVERSTITCH SX¿ ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746 ; 5122795114
• MDR Report Key: 17011458
• MDR Text Key: 316043820
• Report Number: 3006722112-2023-00129
• Device Sequence Number: 1
• Product Code: OCW
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ESS-G02-SX1
• Device Catalogue Number: ESS-G02-SX1
• Device Lot Number: 2023010305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2022
• 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 Outcome(s): Death; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female