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

Model Number BML-V242QR-30

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

In speaking with olympus technical support via the phone, the olympus representative stated all the available information was being provided at the time of the call.The device was not available to be sent back to olympus for failure analysis as it was disposed of by the facility.The subject device referenced in this report was not returned for evaluation.Therefore, the device evaluation could not be completed at this time.The exact cause of the reported event could not be conclusively determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus representative reported on behalf of the customer, during a therapeutic endoscopic retrograde cholangiopancreatography (ercp), a stone was stuck in the single use mechanical lithotriptor v and initially could not be removed from the patient or through the endoscope.The facility was performing the procedure to try to crush the stone and the stone became stuck and the user could not remove the device.The stones were crushed with electrohydraulic lithotripsy (ehl) via the spyglass catheter percutaneously via the liver access.Once the stones were broken up enough the mechanical lithotriptor was then removed manually.It was known from imaging that the patient had stones, but the amount of material and the size of the stones were unknown until access was obtained.This was a challenging case and was scheduled with percutaneous access also.There was a two (2) hour delay while the patient was under general anesthesia.The intended procedure was completed but not with the same device.The device was inspected prior to use and no abnormalities were noted.It was unknown if the device had ever been serviced by a third party.No patient harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.Reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The device was manufactured in february 2021.The root cause of the issue could not be conclusively specified.Based on the investigation results in the past, it was likely that the calculus got stuck in the basket due to the following reasons: the calculus was so large.The multiple calculi were grasped at once.The shape of the calculus was special.The calculus was so hard.The instruction for use (ifu) states the following guidelines: keep pliers or wire cutters so that you can cut the instrument if it is damaged.Also have the olympus bml-110a-1 lithotriptor ready.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.

• 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: 12525291
• MDR Text Key: 281579308
• Report Number: 8010047-2021-12224
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218392
• UDI-Public: 04953170218392
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

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: 12K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC SPYGLASS, M00546610 ; EVIS EXERA II DUODENOVIDEOSCOPE, TJF-Q180V-930; REUSABLE EMERGENCY LITHOTRIPTER, BML-110A-1