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

Model Number 00711146

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Esophagus (2399)

Event Date 09/11/2015

Event Type  Injury  

Manufacturer Narrative

The disposable overtube is a device used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.The user facility reported an esophageal perforation occurred during the endoscopic removal of a food impaction.The patient was hospitalized for the surgical treatment of the perforation.Our investigation is in process.A follow-up report will be submitted once additional information becomes available.

Event Description

The disposable overtube is a device used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.The user facility reported an esophageal perforation occurred during the endoscopic removal of a food impaction.The patient was hospitalized for the surgical treatment of the perforation.

Manufacturer Narrative

The disposable overtube is a device used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.The user facility reported an esophageal perforation occurred during the endoscopic for removal of a food impaction, which included use of the guardus overtube (00711146).The patient was hospitalized for the surgical treatment of the perforation.Through follow up communications, us endoscopy learned the guardus overtube (00711146) was not used with an appropriately sized endoscope.An endoscope reference guide is provided with each guardus overtube, and identifies the endoscope models which are compatible with the device.The endoscope (gif-q140) used in the procedure is identified in reference guide as compatible with the larger sized guardus overtube (00711147), and is not compatible with the guardus overtube (00711146).The user facility could not provide the lot number of the guardus overtube (00711146) which was used in the procedure.The user facility reported the patient has recovered and has been discharged from the hospital.The user facility has been informed of the endoscope compatibility requirements for use with the guardus overtube and an in-servicing of the device will be provided.Information provided in the guardus overtube instructions for use includes: · a baseline egd is recommended prior to overtube usage to minimize potential patient complications.· ensure that the od of the endoscope is compatible with the id of the inner tube with tapered tip (see product number size specifications).· do not use the device if the od of the endoscope is incompatible with the id of the tapered tip inner tube.· performance may be compromised if proper lubrication is not applied to both the inner and outer surfaces of the overtube assembly components and endoscope.· once the overtube assembly is in place and the tapered tip inner tube has been removed, do not advance the outer tube beyond the endoscope.Any migration or advancement of the outer tube could result in tissue entrapment and mucosal injury.

Event Description

The disposable overtube is a device used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.The user facility reported an esophageal perforation occurred during the endoscopic removal of a food impaction.The patient was hospitalized for the surgical treatment of the perforation.

• Brand Name: GUARDUS OVERTUBE - ESOPHAGEAL
• Type of Device: OVERTUBE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: michael oleksa ; 5976 heisley road; mentor, OH 44060 ; 4403586263
• MDR Report Key: 5085080
• MDR Text Key: 26098088
• Report Number: 1528319-2015-00026
• Device Sequence Number: 1
• Product Code: FED
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 00711146
• Device Catalogue Number: 00711146
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: No
• 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