MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON3

Model Number	MAJ-233
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not been returned to omsc.The dhr with the lot number of the subject device was confirmed.No abnormalities detected in the dhr.The subject device was not returned for investigation.Therefore, the phenomenon of the reported event could not be confirmed.However, no abnormalities were detected in the dhr, it can be inferred that there were no quality issues upon shipment from the factory.According to the provided information in the event description indicates that the edge of the balloon was caught in the ridge area of the distal end of the endoscope.Therefore, it can be inferred that the balloon was not attached to the endoscope¿s balloon attachment groove and it was attached to the ridge of the distal end of the endoscope, causing the reported event.The above device handling has warned in the instruction manual.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from user facility who has advised the following; "the rim of the balloon became caught in the ridge on the end of the scope and it was stuck so they were unable to remove it.In order to carry out the procedure he had to fit a second balloon over the top".There was no report of patient injury associated with the event.

• Brand Name: BALLOON3
• 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: 12119929
• Report Number: 8010047-2021-08446
• Device Sequence Number: 14335099
• Product Code: ODG
• UDI-Device Identifier: 04953170360428
• UDI-Public: 04953170360428
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: No Information
• Device Model Number: MAJ-233
• Device Lot Number: OK7147 STERILE 09K
• 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: 06/11/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1