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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

During a literature review it was discovered that the following event occured.The patient has had a peg tube in since childhood and after starting cf therapy withelexacaftor/tezacaftor/ivacaftor and achieving optimal nutritional status,his peg tube was removed after 2 decades of his life.It was report that the otsc failed due to still continue leaking.So a competitor device was used to assist and once that was inplace a backup overstitch was used to close the surgical site and it stopped the leakage.At a 2 month follow-up the patient was still doing fine with not leakage.

Manufacturer Narrative

Combined medwatch submitted to the fda on 23/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 "surgery related observation / complication (leakage)" 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.Device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.

• 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: 17170064
• MDR Text Key: 317640986
• Report Number: 3006722112-2023-00137
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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: 05/31/2023
• 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): Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male