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

Model Number OVT-027-160

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

Patient Problem Perforation of Esophagus (2399)

Event Date 03/31/2021

Event Type  Injury  

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 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
• Type of Device: ENDOSCOPIC OVERTUBE
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX
• Manufacturer (Section G): ROSE MEDICAL; 1440 front ave, nw; grand rapid MI 49504
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 11756200
• MDR Text Key: 248326753
• Report Number: 3006722112-2021-00023
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 10811955020701
• UDI-Public: (01)10811955020701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2021
• 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; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 89