MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. BALLOON

Model Number	MAJ-1351
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and will not be returned to olympus.Although a lot number was not provided, the device history record (dhr) for over the past year prior to the notification date was inspected.No abnormalities were detected in the dhr review which could cause or contribute to the reported problem.An investigation was unable to determine the root cause.However, based on the available information, it was determined that user handling may have contributed to the event due to the following reasons: it was possible that the balloons might have not deflated completely when the endoscope was withdrawn from the patient.The balloon was not lubricated.As a preventive measure, the instructions for use provides the following statements: ·never inflate the balloon to a diameter of more than 20 mm when using the endoscope in the trachea.This could result in suffocation of the patient.·never withdraw the endoscope while the balloon is still inflated.Otherwise, the balloon may burst or come off the distal end of the endoscope.If the balloon cannot be deflated, insert the channel cleaning brush (bw-400b) into the irrigation port.Using slow, short strokes, carefully feed the brush to remove debris.After that, the balloon can be deflated.When withdrawing the endoscope, make sure that the balloon is completely deflated, using the ultrasound image and endoscopic field of view.Withdrawing the endoscope while the balloon is inflated could result in patient injury.Always lubricate the balloon before insertion.Otherwise, the balloon could rupture or come off.This could result in patient injury.Deflate the balloon before withdrawing the endoscope from the patient.Withdrawing the endoscope while the balloon is inflated could result in patient injury.This report has also been submitted on importer medwatch report #: 2429304 - 2023 ¿ 00086.
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that the balloon fell off the evis eus ultrasound bronchofibervideoscope into the patient during an unspecified procedure.The balloon was retrieved.There was no harm or user injury reported due to the event.The customer was unable to provide more information.This event is reported under the following patient identifiers: (b)(6) - balloon.(b)(6) - bronchofibervideoscope.

• Brand Name: BALLOON
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16924245
• Report Number: 9614641-2023-00662
• Device Sequence Number: 20563039
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

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: MAJ-1351
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 04/12/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BF-UC190F / UNKNOWN SERIAL NUMBER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown