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

Model Number BML-V437QR-30

Device Problem Mechanical Problem (1384)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

It was reported that during a therapeutic endoscopic biliary stone removal, it was reported that when using bml-v437qr-30, only the wire part was inserted into the scope before mounting on the bml handle to grasp the stone, and then when trying to mount the bml handle, it could not be connected.The operation pipe did not move well.The bml handle was replaced with a van beck handle and the wire was removed.The stone was removed from the basket by operating the operation pipe , the basket is pulled into the coil sheath.According to the reporter, the new bml completed the procedure.There was no patient harm or injury reported as a result of the event.No user injury reported.

Manufacturer Narrative

(b)(6).The subject device was received and evaluated.The product was bml-v437qr-30.The lot number was "18k" and the supplementary information was "04".Device evaluation, the following were noted: the weld between the operation wire and the operation pipe was broken.There was no problem with the brazed state of the operation pipe, and when the outer diameter of the joint was measured, there was no abnormality.The basket wire was noted to be broken.When the outer diameter of the basket wire was measured, there was no abnormality.When connected the actual wire joint to maj-441 (olympus reference tool handle), it was able to connect and fix without any problem.In addition, when tried connecting the fixed pipe of the actual product to maj-441, it was able to connect and fix without any problem.There were no other abnormalities related to the event reported.The device's instruction manual provides the following : ifu (instruction for use) : do not use this product for gallstones that are not expected to be crushed with this product.The operation pipe or basket wire may be damaged and a part of this product may remain in the body.Before using this product, prepare for the transition to surgery and hospitalization plan in case the stone cannot be crushed.Please use it after preparing the transition to surgery and hospitalization plan in case the stone cannot be crushed with this product.This product is intended to be used only when surgical operations are possible as an emergency measure.In the unlikely event that the gallstones are hard, damage as shown in "chapter 5 emergency measures" may occur.Before using this product, fully understand the possibility of damage to the crushed stone tool and the possibility of transition to surgery.By crushing stones, each part of this product will be deformed and deteriorated.Repeated crushing will cause further deformation and deterioration.Deformation and deterioration may make it impossible to crush stones, or the crushed stones may not be pulled out of the body while holding the gallstones.If the stone is repeatedly crushed during one case, check that there are no abnormalities in the operation and appearance (breaking of basket wire, fraying, buckling of tube sheath, significant buckling or displacement of coil sheath, etc.) each time.Do not use if you feel.When crushing stones, keep the coil sheath to the bml handle as straight as possible against the forceps plug of the endoscope.The coil sheath may buckle and cannot be crushed, and the crushed stone tool may not be pulled out of the body while holding the gallstone.Do not rotate the knob on the bml handle abruptly.This product may be damaged and crushed stones may not be formed, or the crushed stones may not be pulled out of the body while holding the gallstones.Evaluation findings found the device basket was observed to be broken , however, the reported issue of bml handle connection part and cannot be connected was not able to be duplicated.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the final legal manufacturer¿s investigation and the device history record (dhr) review.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the results of the investigation, it is likely the operation pipe could not be moved properly because the operation pipe was broken.The exact cause of the failure is unknown, however, the investigation determined contributing factors.When the operation pipe and bml handle were connected and the bml handle was operated, a large load exceeding the strength resistance was applied to the product due to factors such as the size, hardness, and shape of the stone, and the operation pipe broke.In addition, after the operation pipe is broken, when the operation wire is attached to the burnbeck handle to crush the stone, a large load exceeding the strength resistance is applied to the product due to factors such as the size, hardness, and shape of the stone, and the operation pipe breaks.Olympus will continue to monitor the field performance of this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14309445
• MDR Text Key: 299682165
• Report Number: 8010047-2022-07739
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218415
• UDI-Public: 04953170218415
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V437QR-30
• Device Lot Number: 18K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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: TJV-Q290V DUODENOSCOPEVAN BECK HANDLEBASKET