MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number	BML-V232QR-26
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the single use mechanical lithotripter v was used to break the gallstones, however the device handle was spinning and unable to break the stones.The device handle was rotated while the tube sheath was extended from the coil sheath during use.The wire was broken as an emergency response.As a result, the procedure was completed by forcibly crushing the stones using a non-olympus device.The procedure was prolonged by about 15 minutes but no additional anesthesia was required.No additional diagnostic or medical interventions were undertaken.Patient did not experience any adverse effects or complications and patient's current condition/outcome was reported as "no problems" identified.There were no health hazards reported to the patient.
Additional Manufacturer Narrative
E1: the complete establishment name is - (b)(6) hospital.The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.The subject device was manufactured on feb, 2023 based on the provided 3 digit lot information.
Event or Problem Description
During use, the bml handle was turned with the actual tube sheath protruding from the coil sheath.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.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, it is likely the reported event might have occurred due to wrong handling, not to defects of the device.However, the subject device was not returned and the root cause of the suggest event could not be determined.The event can be prevented by following the instructions for use which state: "when making the coil sheath slide, confirm under x-ray image that the tube sheath is completely covered by coil sheath.If not completely covered, the calculus may not be crushed and/or the instrument with calculus engaged may not be removed from the body." "during lithotripsy, make sure to have the knob of the coil sheath properly set in the groove of the slider part.If the coil sheath moves, the stone may not be crushed and/or the instrument with calculus engaged may not be removed from the body." "to prevent damaging the instrument, the rotatable knob on the bml handle can be turned even when the holder is fully extended.At this point, the basket cannot be pulled in any further.In that case, stop turning the rotatable knob." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Common Device Name: SINGLE USE MECHANICAL LITHOTRIPTOR
• 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: 18034956
• Report Number: 9614641-2023-01638
• Device Sequence Number: 20654905
• Product Code: LQC
• UDI-Device Identifier: 04953170218347
• UDI-Public: 04953170218347
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: BML-V232QR-26
• Device Lot Number: 32K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/16/2023
• 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: UNKNOWN MANUFACTURER-ENDOTRICCTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown