MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERTUBE ENDOSCOPIC ACCESS SYSTEM; ENDOSCOPIC OVERTUBE

Model Number	OVT-027-160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial medwatch submitted to the fda on 30/apr/2021.A review of the device labeling notes the following: the current overtube¿ endoscopic access system (ess) instructions for use (ifu) addressed the known and potential event of "overtube-interference/fit with overstitch" and "perforation" as follows: warnings:do not use device where the integrity of the packaging has been compromised or if the device appears damaged.Lubrication required.Generously lubricate inner and outer surfaces of the overtube with water soluble lubricant prior to use.During insertion or removal of the overtube, do not advance or retract against resistance.Inspect the device for any bends, kinks, or other signs of damage.If damaged, do not use the device.Ensure that the tapered tip of the overtube forms a gap-free interface with the outer diameter of the endoscope, and that it slides freely over the endoscope.Possible complications that may result from using the overtube include, but may not be limited to: · pharyngeal, esophageal or bowel perforation.· pharyngeal, esophageal or bowel laceration.The labeling is adequate as it addresses the reported complaint.The occurrence of this reported complaint for this product will continue to be monitored as appropriate.
Event or Problem Description
On 31/mar/2021 received uf/importer report # (b)(4).Reported: during the insertion of the or's scope into the overtube device, an esophageal perforation was noted just distal to the overtube.The device was immediately removed and endoscopic clips were placed to close the perforation.

• Brand Name: OVERTUBE ENDOSCOPIC ACCESS SYSTEM
• Common Device Name: ENDOSCOPIC OVERTUBE
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX
• MDR Report Key: 11756200
• Report Number: 3006722112-2021-00023
• Device Sequence Number: 14251210
• Product Code: FED
• UDI-Device Identifier: 10811955020701
• UDI-Public: (01)10811955020701
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K122270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OVT-027-160
• Device Catalogue Number: OVT-027-160
• Device Lot Number: 2010-2043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 89