MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON

Model Number	MAJ-1351
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation as the device was discarded by the user facility staff following the procedure.Based on similar reported events, the most likely cause of the reported event is user handling.The ifu states: "as a preventive measure, the instruction manual provides warning and cautions that states: never tie the elastic opening of both sides of the balloon with a thread.This may cause the balloon to rupture or detach from the distal end of the endoscope when inflating it, and could result in patient injury.Never withdraw the endoscope while the balloon is still inflated.Otherwise, the balloon may burst or detach from the distal end of the endoscope.Always lubricate the balloon before insertion.Otherwise, the balloon could rupture or come off.This could result in patient injury." if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
It was reported by the user facility that the balloon slipped off the scope at some time during the procedure, or when the scope was placed back on the table after the procedure was completed.Customer performed a chest x-ray and bronchoscopy post-procedure and confirmed that the balloon was not left in the patient.There is no patient injury or adverse outcome reported.

• Brand Name: BALLOON
• Common Device Name: BALLOON
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8928621
• Report Number: 8010047-2019-03026
• Device Sequence Number: 18899259
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1351
• Device Lot Number: 91K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1