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

Model Number BML-V442QR-30

Device Problems Break (1069); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.Preliminary findings are reported.Physical evaluation of the suspect device: olympus performed a visual inspection on the received condition and was unable to test the device due to the device was received broken/damage into multiple pieces (see attached) pictures.The entire basket wire is broken off/detached from the sheath.The wire joint and basket wire tip were both missing.Olympus observed multiple kinks/frayed wires on the basket wire.There was also kinks noted with the sheath.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2429304-2022-00069.

Event Description

The customer reports during an endoscopic retrograde cholangiopancreatography (ercp) using a single use mechanical lithotriptor, the physician used the device to crush the stone, and the device became impacted/failed.The user then cut the wire and attached the emergency handle.They used another manufacturer¿s emergency handle to remove the basket, but all four wires on the basket broke, and the top part of the basket fell inside the patient.Next, they brought in some sort of laser and performed lithotripsy on the stone.They were able to retrieve the fallen part.Before they used the olympus stone crushing basket, they had used another manufacturer¿s retrieval basket.This basket got broke and got stuck i the bile duct, so they tried an olympus basket and the olympus basket failed as well.The intended procedure could not be completed at that time due to the two different baskets breaking.Patient stayed overnight in the hospital.The procedure was rescheduled for the following day.The case was completed successfully the next day using a special laser in or.The special laser was used to remove the boston scientific basket and the stone.The patient is fine.No known infection occurred due to the issue reported.

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.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, due to various factors such as the size, hardness or shape of the calculus, a load beyond the resistance strength likely applied to the product during the lithotripsy.As a result, the operating pipe and/or operating wire was possibly broken, and the device could not be retracted.Also, during the emergency lithotripsy (with the cook emergency handle), due to various factors such as the size, hardness or shape of the calculus, a load beyond the resistance strength likely applied to the product.As a result, the basket wires were broken, and the top part of the basket fell inside the patient.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿before use, thoroughly review the method of use for this instrument and bml-110a-1 in accordance with the instruction manuals.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 lithotripter 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 ¿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.Before each case, prepare and inspect the instrument and bml handle as instructed below.Inspect other equipment to be used with the instrument and bml handle as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use the instrument or bml handle; contact olympus.Damage or irregularity may compromise patient or user safety, which poses an infection control risk, and can cause tissue irritation, perforation, bleeding, or mucous membrane damage and may result in more severe equipment damage.Never use excessive force to operate the instrument and bml handle.This could damage the instrument and/or bml handle.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.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 ¿emergency treatment¿ may occur.Use this instrument by considering that it may lead to damage of 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.Lower the endoscope¿s forceps elevator when performing lithotripsy.If lithotripsy is performed when the elevator is not lowered, the scope or the instrument may break and/or the calculus may not be crushed.Also, the instrument with calculus engaged may not be removed from the body.If the calculus is too hard and the instrument is damaged, it may be necessary to use the bml-110a-1.In this case, also refer to the instruction manual for the bml-110a-1.¿ this supplemental report includes a correction to d4 (lot number) from initial medwatch.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 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15519944
• MDR Text Key: 301040355
• Report Number: 9614641-2022-00394
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 16K03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• 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
• Patient Outcome(s): Other; Required Intervention