MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON CONTROL UNIT

Model Number	OBCU
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unspecified therapeutic procedure, when the foot pedal was pressed to inflate the balloon, the balloon over inflated to 10 kilo-amps.Subsequently, the patient experienced perforation.Additional information is unavailable at this time.The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.
Event or Problem Description
This is a supplemental report to provide additional information regarding the procedure and the patient.Procedure: therapeutic single balloon enteroscopy.No other devices were involved in the event.The procedure was not completed.The device failed at the beginning of the procedure.

• Brand Name: BALLOON CONTROL UNIT
• Common Device Name: BALLOON CONTROL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10555535
• Report Number: 2951238-2020-00491
• Device Sequence Number: 2681854
• Product Code: FDA
• UDI-Device Identifier: 04953170237461
• UDI-Public: 04953170237461
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020
• Report Date (Section F): 10/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: OBCU
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/26/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Weight: 50