MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ORACLE EUS BALLOON; ECHOSCOPE TRANSDUCER BALLOON

Model Number 00711891

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Type  No Answer Provided  

Manufacturer Narrative

The oracle eus balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the upper and lower gastrointestinal tract.Us endoscopy received a report from a user facility concerning three events that occurred approximately six months prior to report.The report indicates that following three procedures which included the use of an oracle eus balloon the physician noticed superficial mucosal tears in the esophagus.No treatment was required for the superficial mucosal tears.The subject device was not returned for evaluations.The lot number of the device was unknown.Review of complaint history for this device finds no similar reports.

Event Description

The oracle eus balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the upper and lower gastrointestinal tract.Us endoscopy received a report from a user facility concerning three events that occurred approximately six months prior to report.The report indicates that following three procedures which included the use of an oracle eus balloon the physician noticed superficial mucosal tears in the esophagus.No treatment was required for the superficial mucosal tears.

• Brand Name: ORACLE EUS BALLOON
• Type of Device: ECHOSCOPE TRANSDUCER BALLOON
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 6282925
• MDR Text Key: 65962683
• Report Number: 1528319-2017-00004
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 00711891
• Device Catalogue Number: 00711891
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other