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

Model Number BML-V442QR-30

Device Problem Difficult to Open or Close (2921)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation has not been completed; therefore, the user¿s complaint has not been confirmed.We are unable to determine a root cause for the reported event.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The user facility reported that there was an issue with the device.During a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the user assembled the basket and the handle according to the instructions.When the physician wanted to capture the first gall stone, he took out the basket in the common bile duct and captured a first stone of about 1cm.He wanted to close the basket to crush the stone.The basket did not appear to close as usual and he was unable to crush the stone.He took the basket out of the common bile duct and the stone was released into the duodenum.It was impossible to put the basket in the sheath to return to the common bile duct.The mechanism no longer worked.He decided to put a plastic stent in the bile duct and go back in a few weeks to try and capture the bigger stone which must be around 20mm.The patient was agitated, and the physician did not want to take the time to take out another basket to continue, so he decided to stop.Nothing has happened to the patient; she is in good health and the procedure will be resumed later.There was no patient injury or harm.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information from the legal manufacturer regarding the final investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The device history record for the lot indicated no anomaly with the event-related items below.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: based on the similar investigation results in the past, a likely mechanism causing the reported event might be the following.1)due to various factors such as the shape, numbers, hardness of the calculus, and the magnitude of the force necessary to close the basket, it can be inferred that a force larger than expected might have been applied to the device while the basket was grasping the calculus.2)due to in state of ¿1¿ description, the basket became incarcerated.3)an attempt was forcefully made to retract the basket by pulling the operation pipe, causing the joint between the operation pipe and the wire to break.4)the basket could not be moved because the operation pipe broke.The legal manufacturer reported that the instruction manual provides the statements below.Never use excessive force to operate the instrument and bml handle.This could damage the instrument and/or bml handle.Make sure the screw is tightened.If not securely tightened, the pipe may detach, the basket may not to be moved, and/or the calculus may not be crushed.Make sure to have the stopper and the bml handle connected.If the instrument separates from the bml handle during operation, the pipe may break or become uncontrollable.Also, this instrument with calculus engaged may not be removed from the body.When the lithotriptor¿s basket does not smoothly open or close, do not apply force but move the forceps elevator or the scope¿s angle back, or move the position of the basket until the basket opens or closes with ease.If the action is forced, the tube may stretch and cannot be stored inside the coil sheath.Also, the calculus may not be crushed, and/or the instrument with calculus engaged may not be removed from the body.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.

• 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: 10673354
• MDR Text Key: 224636144
• Report Number: 8010047-2020-07631
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2021

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-V442QR-30
• Device Lot Number: 7ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1