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

Model Number	MAJ-441
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not been returned to olympus for evaluation.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.
Event or Problem Description
The customer reported to olympus that the basket could not be removed while using bml handle v during a therapeutic procedure lithotripsy electromagnetic eml.The single use mechanical lithotriptor v bml was removed together with the scope, and another jf-260v and bml were used to complete the procedure.After confirming the malfunctioning scope and instrument, it was confirmed that the bml sheath was caught in the forceps elevator.It was also confirmed that the bml sheath could not be removed from the bml handle.There was no patient harm associated with the event.This report is for the bml handle v (model number: maj-441, serial number: (b)(4).Patient identifier (b)(4) captures the complaint on the evis lucera duodenovideoscope (model umber: jf-260v, serial number: (b)(4).Patient identifier (b)(6) captures the complaint on the single use mechanical lithotriptor v (model number bml-v437qr-30, serial number: (b)(4).
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.H4: based on the 3 digit lot number provided, the manufacturing date of the device was in the month of may 2016 but a specific date could not be identified.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.The protrusion of maj-441 was properly engaged with the handle engagement groove of bml-v437qr-30.There were no abnormalities of the connecting condition.Additionally, the maj-441 was able to operate the basket with no problem and the maj-441 was removed from bml-v437qr-30 with no problem.The device history record was unable to be reviewed for this device as the device only has a 3-digit lot number.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the non-functional maj-441 device was unable to be determined.However, probable causes for the reported event (kinked sheath/coil sheath/stones stuck in basket) include: 1) due to various factors such as the size, hardness or shape of the calculus, a load beyond the resistance strength applied to bml-v437qr-30 during the lithotripsy.2) as a result, the coil misaligned, and the coil sheath was deformed.3) an attempt was made to remove the device from endoscope.However, the deformed portion of the coil sheath got stuck at the forceps elevator.This prevented the device from removing from the endoscope.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: 16681642
• Report Number: 9614641-2023-00467
• Device Sequence Number: 18185622
• 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): N
• 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): 06/09/2023

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: 65K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2016
• 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: MODEL NUMBER BML-V437QR-30, SERIAL NUMBER: (B)(6); MODEL NUMBER: BML-441, NO SERIAL NUMBER PROVIDED; MODEL UMBER: JF-260V, SERIAL NUMBER: (B)(6)
• Patient Sex: Unknown