MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. GUARDUS OVERTUBE - ESOPHAGEAL

Model Number	00711147
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inner tube of the guardus overtube is intended to be removed following intubation.The instructions for use include the following statements: "after removing the components of the overtube assembly from the packaging, generously lubricate the inner and outer surfaces of both tubes with a water soluble lubricant.Performance may be compromised if proper lubrication is not applied to both the inner and outer surfaces of the overtube assembly components and endoscope.Turn the proximal lock on the color coded inner tube cap counter-clockwise to unlock it from the handle of the outer tube.Maintain position of the outertube's handle manually.Withdraw both the tapered tip inner tube and endoscope simultaneously from the patient." the device subject of this event has not been returned to steris endoscopy for evaluation.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Steris endoscopy has offered in-service training on the use of the guardus overtube to the user facility; however, the facility has declined.No further issues have been reported.
Event or Problem Description
The user facility reported the inner tube could not be removed from the overtube after placement in the esophagus during a food bolus procedure on a patient with a tortuous upper esophagus.Contrary to the instructions for use, the procedure was completed without removal of the inner tube.Following the procedure, the patient was treated for an esophageal tear; however, it is not clear how use of the overtube with the inner tube in place contributed to the reported injury.

• Brand Name: GUARDUS OVERTUBE - ESOPHAGEAL
• Common Device Name: OVERTUBE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• MDR Report Key: 10176382
• Report Number: 1528319-2020-00019
• Device Sequence Number: 14355230
• Product Code: FED
• UDI-Device Identifier: 00724995183622
• UDI-Public: (01)00724995183622
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2022
• Device Model Number: 00711147
• Device Catalogue Number: 00711147
• Device Lot Number: 1916853
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1