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

Model Number	MAJ-441
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the user attempted to crush the bile duct stone with the bml-v437qr-30 (single use mechanical lithotriptor v), however, it was difficult because the stone was hard.It was noted, when the knob of the bml handle v was turned forcefully, the connecting part between the bml sheath and the handle broke.Subsequently, the intended procedure was completed with a similar device, with no delay and no harm or user injury reported due to the event.Patient identifier (b)(6) captures the related event on the single use mechanical lithotriptor v.
Additional Manufacturer Narrative
The serial number of the subject device was not provided.The subject device has been returned to olympus for evaluation and the reported issue was confirmed.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, correction to g2, and the device evaluation.Please see updates to d4, g2, h4, h6 and h10.H4: based on the 3 digit lot number provided, the manufacturing date of the device was in the month of june 2017 but a specific date could not be identified.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The operation pipe (the connection between the bml sheath and the handle) was broken.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a probable cause for the gall stones temporarily stuck in the basket include: 1.Due to various factors such as the shape, numbers, hardness of the calculus, a force beyond the strength resistance was applied to the device during the lithotripsy.2.Due to the described above, deformation of the basket and misalignment of the coil sheath occurred.And the operating pipe broke at the brazing joint.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17215827
• Report Number: 9614641-2023-00915
• Device Sequence Number: 20391378
• Product Code: LQC
• UDI-Device Identifier: 04953170218446
• UDI-Public: 04953170218446
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K903529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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-441
• Device Lot Number: 76K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2017
• 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: SERIAL: (B)(6) MODEL: MAJ-441.
• Patient Sex: Unknown