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

Model Number BML-V242QR-30

Device Problem Mechanical Jam (2983)

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

Event Date 01/30/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the single use mechanical lithotriptor v jammed after capturing the patient¿s gallstone.When the knob on the slide was pushed forward, the spiral tube jammed up inside.Initially, the basket could not be released, and the button could not be pushed back in the slide.After several attempts and various movements of the duodenovideoscope, the tension was released, and the stone was removed without being crushed.The issue occurred during the therapeutic procedure (stone fragmentation ercp), and the procedure was completed with three stone retrieval baskets and replacement with a similar device.There was no patient harm associated with the event.

Manufacturer Narrative

The device is expected to be returned for evaluation but has not yet been received.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.This report is related to linked patient identifier (b)(6) and submitted med watch 135123.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.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¿s likely the gall stones were temporarily stuck in the basket and the coil misaligned due to various factors such as the size, hardness or shape of the calculus, as a result it¿s probable a load beyond the resistance strength might have applied to the product during the lithotripsy.Additionally, it¿s likely the knob of the handle could not be operated due to misalignment of the coil.The final root cause of this event was unable to be identified.The following is included in the instructions for use: ¿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.Use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case the calculus cannot be crushed by lithotriptor bml-110a-1.A lithotriptor cannot always crush all calculi captured in the basket.Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard, it is possible that the damages shown in chapter 5, ¿emergency treatment¿ may occur.Use the lithotriptor by considering that it may lead to damaging the instrument and that open surgery may have to take place.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.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.

• 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: 16441173
• MDR Text Key: 310270750
• Report Number: 9614641-2023-00274
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/05/2023

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-V242QR-30
• Device Lot Number: BML 1YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/26/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• 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: TJF DUODENOVIDEOSCOPE