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

Model Number ESS-G02-SX1

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Esophagus (2399)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 31/mar/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" as follows: warnings: ensure that there is sufficient space for the needle to open.Ensure that the handle grip of the endoscopic suturing system is closed and locked during intubation and extubation.Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing synthetic absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.Adverse events possible complications that may result from using the endoscopic suturing system include, but may not be limited to: pharyngitis / sore throat.Additional information: the investigator determined that a device history record (dhr) review is not possible for this complaint, as the device serial and lot number are currently unknown.

Event Description

After suturing was completed the esophagus was checked and it was found no tear or perforation.However it was found a tear in the right hypoharynx, patient was admitted in the hospital for n.P.O and iv.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 04/may/2023.Additional information: the device has not been returned for analysis.The investigator determined that a device history record (dhr) review is not possible for this complaint, as the device serial and lot number are currently unknown.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 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: 16656064
• MDR Text Key: 312501857
• Report Number: 3006722112-2023-00061
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020718
• UDI-Public: (01)10811955020718(
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 85 KG