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

Model Number ESS-G02-160

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Syncope/Fainting (4411); Gastrointestinal Hemorrhage (4476)

Event Type  malfunction  

Event Description

This report was from an literature review.It was reported that post -operative bleeding occurred and oesophageal mucosal tearing occurred during the overtube being inserted (who had previously undergone thyroid surgery).Patient was hospitalized for a short stay (was not reported how many days).

Manufacturer Narrative

Initial medwatch submitted to the fda on 31/mar/2023.A review of the device labeling notes the following: the apollo endosurgery overstitch¿ 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 after multiple attempts to gather more information from the reporter, no additional information has been received.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM
• Type of Device: ENDOSCOPIC SUTURE 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: 16657421
• MDR Text Key: 312500128
• Report Number: 3006722112-2023-00072
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: (01)10811955020664
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/30/2022

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-G02-160
• Device Catalogue Number: ESS-G02-160
• Was Device Available for Evaluation?: No
• 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