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

Model Number BML-V442QR-30

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/27/2023

Event Type  Injury  

Event Description

The olympus employee reported on behalf of customer that during therapeutic biliary stenting procedure, the tip of the guide wire became extremely dirty after the stone was broken and device tip fell inside the digestive tract and could not be collected per doctor's discretion.The procedure was completed by replacing it with similar equipment.No medical/diagnostic intervention undertaken to retrieve the broken device as it is expected to pass naturally since device fell inside patient's digestive tract.No procedure is planned to remove the fallen device.No additional sedation needed, nor prolongation of procedure occurred or any serious deterioration in the state of health of the patient.The patient outcome due to procedure is unknown, however no clinical impact or patient harm was reported.The device was not inspected prior to use.

Manufacturer Narrative

E1.Full hospital name: (b)(6) hospital.The device was returned to olympus for evaluation.The product was found to be non-conforming.The actual product was inspected and guidewire tip was disconnected.The guidewire tip had traces of adhesive applied all around the perimeter.In addition, there were no other abnormalities related to the event in the actual product.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 likely cause of a reported problem might be the guidewire tip region was bent for some reasons.This could have caused the adhesion peeling between the guidewire tip and the distal tip.As a result, the guidewire tip came off.However, the a specific root cause could not be determined.The event can be prevented by following the instructions for use which state: "when inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve.Otherwise, the insertion portion could be damaged." "insert the instrument slowly.Abrupt insertion may damage the endoscope and/or instrument." olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17989689
• MDR Text Key: 326321224
• Report Number: 9614641-2023-01573
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• 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: 36K06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• 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
• Patient Outcome(s): Other