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

Model Number ESS-G02-SX1

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

A review of the device labeling notes the following: the apollo endosurgery overstitchsx¿ endoscopic suture system (ess) is intended for endoscopic placement of suture(s) and approximation of soft tissue.Warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Contact of electrosurgical components with other components may result in injury to the patient and/or operator as well as damage to the device and/or endoscope.Verify compatibility of endoscopic instruments and accessories and ensure performance is not compromised.Note: refurbished scopes may no longer confirm to original specifications.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.Additional information: the device has not been returned for analysis and attempts to gather more information from the reporter is not visible as this is a literature review, and the author does not have the information for the device.The investigator determined a device history record (dhr) review is not possible.

Event Description

The event was from an literature review and the patient had pain and bleeding.Repaired the bleeding with overstitchsx.No future complications and patient doing well.

• Brand Name: OVERSTITCHSX¿ 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, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5128523757
• MDR Report Key: 15320428
• MDR Text Key: 302600442
• Report Number: 3006722112-2022-00083
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• 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: 05/14/2022
• 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
• Patient Outcome(s): Required Intervention