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

Model Number ESS-G02-SX1

Device Problems Material Perforation (2205); Mechanical Jam (2983)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 15/sep/2023.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of esophageal laceration as follows: the apollo endosurgery overstitch¿ endoscopic suture system (ess) is intended for endoscopic placement of suture(s) and approximation of soft tissue.Contraindications include those specific to use of an endoscopic suturing system, and any endoscopic procedure, which may include, but not limited to, the following: · this system is not for use where endoscopic techniques are contraindicated.· this system is not for use with malignant tissue.Adverse events 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 note: any serious incident that has occurred in relation to the device should be reported to apollo endosurgery (see contact information at the end of this document) and any appropriate government entity.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being mdr reportable.There are no other complaints against this lot number (2022051243) and allegation.

Event Description

Healthcare professional reported after deploying the cinch and cutting the suture, the needle body could not be closed due to unknown reasons.It caused a patient esophagus laceration when removing it from the endoscope.

Manufacturer Narrative

Supplemental medwatch submitted to the fda on 06nov2023.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being mdr reportable.The subject product met all specifications and requirements in effect at the time of manufacture.There are no other complaints against this lot number (2022051243) and allegation.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 09/oct/2023.One needle driver and anchor exchange were returned for investigation.Prior to decontamination, engineering functionally tested the device.The handle opens and closes as intended; however, due to the bent needle body tip, the tip does not go into the endcap.Under microscopic analysis, the needle body tip is severely bent.The complaint has been verified as the needle body is bent; therefore, will prevent it from closing.Lab analysis was able to replicate the reported event of "overstitch-difficulty closing needle body", as the needle body is severely bent.The user effect of "overstitch-difficulty closing needle body" is known and labeled possible adverse 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: 17755096
• MDR Text Key: 323494068
• Report Number: 3006722112-2023-00179
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020718
• UDI-Public: (01)10811955020718(17)20250430(11)20220430(10)2022051243
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS-G02-SX1
• Device Catalogue Number: ESS-G02-SX1
• Device Lot Number: 2022051243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2022
• 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): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 29 KG