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

Model Number ESS-G02-160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) of Esophagus (2398)

Event Type  Injury  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.To date, the device has not been received by apollo.Device labeling addresses the reported event as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Ensure that there is sufficient space for the needle to open.Warning: do not introduce the device with the needle body in its open position.Adverse event: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: abdominal pain and / or bloating.Pharyngeal, colonic and/or esophageal perforation.Esophageal, colonic and/or pharyngeal laceration.Intra-abdominal (hollow or solid) visceral injury.

Event Description

Reported as: "other aes were graded as mild (24 out of 342 cases; 7.0%).These included submucosal esophageal tear requiring clipping or suturing (5), superficial mucosal esophageal abrasion not requiring an intervention (5), oozing from a suture site that stopped spontaneously (4), bleeding at a suture site requiring either epinephrine injection or early cinching to tamponade (3), suture breakage (1), abdominal pain (3), nausea (1), non-cardiac chest pain (1) and severe constipation (1).".

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 24/mar/2020.Additional information: d4.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 9592468
• MDR Text Key: 181232974
• Report Number: 3006722112-2020-00008
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• 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
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention