MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number BML-V442QR-30

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the customer's experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during a procedure using a single use mechanical lithotriptor v, the stone was captured in the basket and on attempting to crush it, the wires of the basket snapped in the device using the regular lithotriptor handle.The wires were then fed through a rescue sheath and rescue handle.Upon tightening the wires, they again snapped in the rescue handle between the winding device and the front of the handle.The procedure was later completed in a separate surgery to remove stones, and remove device fragments.No additional information could be provided by the customer regarding the patient or event.

Manufacturer Narrative

This report is being updated to provide investigation findings and additional information provided by the customer.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: ·do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotriptor.The pipe or the basket wire may break and part of this instrument may remain in the body.·never use excessive force to operate the instrument and bml handle.This could damage the instrument and/or bml handle.·do not open and close the basket too quickly.Doing so could damage the instrument.·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.·do not use this lithotriptor bml-110a-1 for a calculus that is assumed impossible to be crushed by this lithotriptor.The basket wire etc.May break and part of this lithotriptor may remain in the body.Conclusion: the definitive root cause of the reported event could not be determined.Based on the available information the following are presumed to be possible causes of the reported event: -an attempt was made to crush the calculus continuously by using bml-110a-1; however, due to various factors such as the shape, numbers, hardness of the calculus, and the magnitude of the force necessary to close the basket wire, it can be inferred that a force larger than expected might have been applied to the device while the basket wire was grasping the calculus.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: SINGLE USE MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11219404
• MDR Text Key: 230775222
• Report Number: 8010047-2021-01753
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V442QR-30
• Device Lot Number: 04K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention