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

Model Number BML-V237QR-30

Device Problems Difficult to Advance (2920); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation.When checking the device physically, the tube sheath was deformed and compressively buckled.When operating the slider, the coil sheath got caught in the compression buckling part of the tube sheath, and couldn't fully pull the tube sheath into the coil sheath.The tube sheath protruded from the coil sheath.Part of the tube sheath was compressively buckling.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The olympus employee reported on behalf of the customer that during a therapeutic lithotripsy procedure, the sheath of bml-v237qr-30 - single use mechanical lithotriptor v was deformed and twisted into the biliary tract and did not enter the coil, causing the stone to remain incarcerated.The doctor cut the treatment tool in accordance with the instruction manual and crushed the stone using a bml-610a -single-use emergency lithotriptor handle and procedure was able to be completed without causing any harm to the patient¿s health.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide an update to field h4 and to provide additional information received through follow up b5.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 that the reported event occurred through the following mechanism: (1) the tube sheath was deformed and deteriorated after numerous attempts to crush the calculus using a lithotripter.(2) due to deformation of the tube sheath, it became impossible to fully retract it into the coil sheath.(3) the calculus was crushed when the tube sheath was not fully covered by the coil sheath.(4) the tube sheath underwent compressive loading, resulting in compressive buckling.(5) the basket grasped the calculus and became lodged, remaining stuck in place.However, a specific root cause of the reported event could not be identified.The event can be prevented by following the instructions for use which state: "the basket wire and operating wire were retracted from the sheath, and they were not returned for investigation." "do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotripter.The pipe or the basket wire may break and part of this instrument may remain in the body." "this instrument will deform and/or deteriorate by performing lithotripsy.When lithotripsy is repeated, it will deform and/or deteriorate furthermore.By such deformation and/or deterioration, calculus may not be crushed and/or the instrument with calculus engaged may not be removed from the body.If lithotripsy is required to be repeated in a single case, make sure to check each time that no abnormality is found in action and/or appearance (e.G.Basket wire cut or worn, tube sheath bent, notable coil sheath bent or gap etc.).Stop use when any abnormality is detected." "during lithotripsy, keep the portion from the coil sheath to the bml handle straight in line with the scope¿s biopsy valve, as much as possible.If not straight, the coil sheath may bend, calculus may not be crushed, and/or the instrument with calculus engaged may not be removed from the body." "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." "do not rotate the bml handle knob abruptly.This instrument may break, and/or calculus may not be crushed.Also, the instrument with calculus engaged may not be removed from the body." olympus will continue to monitor field performance for this device.

Event Description

It was reported that the incarceration was released by cutting and using a handle, so there was an extension of about five minutes.No additional anesthesia required and the patient did not experience any adverse effects or complications.No additional problem or impact to the patient.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18460342
• MDR Text Key: 332257973
• Report Number: 9614641-2024-00032
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V237QR-30
• Device Lot Number: 34K06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EMERGENCY LITHOTRIPTOR HANDLE BML-610A, SN UNK
• Patient Outcome(s): Required Intervention