MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. BML HANDLE V

Model Number	MAJ-441
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic ercp (endoscopic retrograde cholangiopancreatography) under sedation, an attempt was made to release impaction using the handle, but it could not be released.The guidewire of the single use mechanical lithotripter was tangled in the basked.After the basket was removed, the enbd was placed in the bile duct and the procedure was completed.Due to the device malfunctions, the procedure was prolonged by 45 minutes.There were no reports of patient harm.
Additional Manufacturer Narrative
Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor the field performance of this device.This report is related to (b)(6).

• Brand Name: BML HANDLE V
• Common Device Name: HANDLE
• 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: 21022209
• Report Number: 9614641-2024-20135
• Device Sequence Number: 9207487
• Product Code: LQC
• UDI-Device Identifier: 04953170218446
• UDI-Public: 04953170218446
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/26/2024

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-441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BML-V437QR-30
• Patient Sex: Unknown