MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. 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	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
A customer submitted a medsun report to fda (united states food and drug administration) stating, the remnant of a balloon was left behind on a scope after an endoscopic ultrasound and went through the high-level disinfection process.It is not clear if the balloon was not fully removed prior to reprocessing or it broke, leaving the elastic band behind.This went unnoticed due to the color of the balloon being a similar color to that of the scope.A new balloon was then applied over the remnant and utilized on a second patient.This placed the patient at risk of potentially being exposed to a bloodborne pathogen.There was no report of patient harm associated with this event.There is a request to consider manufacturing balloons in a different color other than off-white, to ensure the balloon is easily identifiable.There were no alerts when the subject device was going through the high-level disinfection process.The remnant was not identified until after the procedure was completed.The intended procedure was a diagnostic endoscopic ultrasound with biopsy.The patient was offered lab monitoring for communicable agents such as human immunodeficiency virus (hiv) and hepatitis (hep b).The hep b lab monitoring was negative.Ther was no report of patient harm associated with this event.Related patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The manufacture date cannot be identified at this time since the lot information was not provided.If the lot becomes available, the manufacturer date will be updated.Based on the results of the investigation, a definitive root cause could not be established.The subject device was not returned to the legal manufacturer.Therefore, the reported phenomenon or condition of the device could not be confirmed.It is possible that the balloon was not securely removed from the scope after surgery, which could have caused the event you described.The instructions for use (ifu) state the following regarding the reported phenomenon: ·picking up the balloon with a clean lint-free cloth makes it easier to remove the balloon.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
The customer confirmed the scope had been through the high level reprocessing process which includes the cleaning according to instruction manual.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.The customer returned one the subject device model number maj-233 lot number unknown in for evaluation for ¿a remnant of the balloon involved was left behind on the scope after the procedure and went through the high-level disinfection process.It is not clear if the balloon was not fully removed prior to reprocessing, or it broke during removal leaving the elastic band behind¿.The balloon was observed under a microscope and found to be torn and mutilated.A functional check was not able to be performed due to the condition of the balloon.

• Brand Name: BALLOON3
• Common Device Name: BALLOON
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17822222
• Report Number: 9614641-2023-01411
• Device Sequence Number: 17673449
• Product Code: FDF
• UDI-Device Identifier: 04953170058783
• UDI-Public: 04953170058783
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2023

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-233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/16/2023; 10/25/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/19/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White