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

Device Problem Migration (4003)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Perforation (2001); Vomiting (2144)

Event Date 06/12/2022

Event Type  malfunction  

Event Description

The reported events were found during a literature review.It was report several patient had the following symptoms - (4 patients) nausea, vomiting, abdominal pain, sore throats, diarrhea and (1 patient) esophageal perforation.The 4 patients were treated conservatively.One patient with the esophageal perforation was treated with a laparoscopic drainage without clinical evidence for perforation.All patients are doing well.

Manufacturer Narrative

Combined medwatch submitted to the fda on 27/jun/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 perforation, nausea, vomiting, pain (abdominal), and other (sore throat) as follows: the apollo endosurgery overstitch¿ endoscopic suture system (ess) is intended for endoscopic placement of suture(s) and approximation of soft tissue.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 and any appropriate government entity.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.

• Brand Name: OVERSTITCH¿ 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: 17210952
• MDR Text Key: 317950893
• Report Number: 3006722112-2023-00134
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• 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