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

Model Number BML-110A-1

Device Problem Mechanical Jam (2983)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

Reports are being submitted on the mechanical lithotripter and retrieval basket.Please refer to the following reports: patient identifier of (b)(6) is related to model number: fg-v435p, serial number: n/a.Patient identifier of (b)(6) is related to model number: bml-110a-1, serial number: n/a.Additional details have been requested regarding the reported event.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported a case of a therapeutic endoscopic retrograde cholangiopancreatography procedure was incarcerated while using the single use retrieval basket v.To release the incarceration, a mechanical lithotripter was used.When the customer cut the sheath on the proximal side of the retrieval basket, it was cut short and it did not come out.By cutting and shortening the coil sheath side of the lithotripter, the handle could be connected and released.The procedure was completed without replacing the equipment.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved 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, and since the device was not returned for evaluation, the definitive root cause of the basket wire issue could not be determined.It is possible that the issue was caused by device handling.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿when cutting the sheath and wire of the grasping forceps or mechanical lithotriptor, leave as much wire as possible to attach to the handle of this instrument.If the wire is too short, it may not be possible to perform the procedure.¿ olympus will continue to monitor field performance for this device.

• Brand Name: MECHANICAL LITHOTRIPTOR
• Type of Device: 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: 16111152
• MDR Text Key: 308655381
• Report Number: 9614641-2023-00014
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170033001
• UDI-Public: 04953170033001
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903529
• 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: 01/31/2023

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
• Device Operator: Health Professional
• Device Model Number: BML-110A-1
• Device Lot Number: ¿¿
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1