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

Model Number OVT-027-160

Device Problems Crack (1135); Inflation Problem (1310); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2019

Event Type  malfunction  

Event Description

The inside of the tube was cracked, causing the device to not inflate and therefore, could not hold tube in place.

• Brand Name: OVERTUBE ENDOSCOPIC ACCESS SYSTEM
• Type of Device: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capital of tx hwy bldg 1, ste 300; austin TX 78746
• MDR Report Key: 9574572
• MDR Text Key: 174488935
• Report Number: 9574572
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 10811955020701
• UDI-Public: (01)10811955020701
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• 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: 1907-2009
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Weight: 157