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

Model Number ESS-G02-160

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Perforation (2001); Peritonitis (2252)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Further information has been requested from the presenter regarding: additional information regarding the reported event, physician information, patient information, and device information.The presentor indicated that they had not seen this patient, and that they would not provide the name of the patient's treating physician.A review of the instructions for use notes the following: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Adverse events possible complications that may result from using the endoscopic suturing system include, but may not be limited to: abdominal pain and / or bloating, infection / sepsis, acute inflammatory tissue reaction.

Event Description

Reported during a medical conference presentation: a patient who underwent an endoscopic sleeve gastroplasty (esg) utilizing the overstitch endoscopic suturing system was noted to have a gallbladder perforation (peritonitis).Additional information noted, "patient underwent surgery 3 days after the procedure due to severe abdominal pain and signs of sepsis.After the surgery [the patient] did well, with no more complaints.".

Manufacturer Narrative

Supplement #1 - medwatch submitted to the fda on 25/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: 8701845
• MDR Text Key: 148143752
• Report Number: 3006722112-2019-00132
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• 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: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 92