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

Model Number BML-V442QR-30

Device Problem Break (1069)

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

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center confirmed via visual inspection and discovered the subject device broken into four (4) separate pieces.The device was not returned in the original package and the lot number was verified through the return material authorization documentation.The four broken pieces consisted of: the insertion portion, pipe, two frayed and torn sections of the basket wire.The end of one section of the basket wire was frayed and the basket at the end of wire was severely bent and twisted.The pipe was broken off with sharp edges and the wire joint at the opposite end was bent.The insertion portion/working length had kinks in numerous locations.A functionality test could not be performed due to the the as received condition of the subject device.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer on mdr number 2951238-2021-00456.

Event Description

The physician reported to the olympus clinical sales specialist, there were multiple olympus device malfunctions during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) performed (b)(6) 2021 and the procedure took four (4) hours long to complete.The physician first attempted the ercp on (b)(6) 2021 but he was unable to get the lithocrush wire around the large stone, approximately 2.2cm stone, and did not want to proceed without his primary support team available for the procedure.The first procedure was uneventful and the olympus device did not malfunction.The patient was kept in the hospital due to elevated laboratory results and the second procedure was planned for the following week.During the second ercp procedure, the physician used an olympus endoscope and inserted the lithocrush basket around the 2.2cm stone and tried to remove the stone with seven (7) different extraction balloons (single-use olympus multi-3v extraction balloons, model and lot number unknown).The physician stated the extraction balloons broke because the stone edges were jagged.The physician then used the lithocrush basket.He proceeded to put the lithocrush basket around the stone and as the seasoned technician withdrawals the wire to crank it down, the lithocrush basket breaks at the ratchet handle.Then, the emergency handle was used, as indicated.The endoscope was removed, a metal sheath was inserted and connect to the emergency handle.As force was being applied to the basket to remove the stone, the wire broke again.There was enough wire viable for another attempt with the emergency handle and the basket broke a 3rd time.At that time, the wire is too short and the emergency handle could no longer be used.The physician proceeded to use a non-olympus laser to lase the stone.However, the first non-olympus laser device was at the end of life and a 2nd device had to be used to lase the stone.Using a non-olympus controlled radial expansion balloon (6x12mm) with biopsy forceps, the basket was retrieved and no foreign material was left behind; this was confirmed by x-ray.A non-olympus 10x6 fully covered metal stent was implanted due to a stone fragment remaining.There was an unknown procedural delay due to the multiple malfunctions.The patient was admitted to the hospital for 24 hour observation and sent home.The patient did not have any post-operative complications.On (b)(6) 2021, the physician¿s partner performed the third ercp with an unknown balloon and basket (not olympus) with further incident.This event includes 1 report for patient identifier (b)(6) for the lithocrush basket.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the device history records (dhr) review.New information was added to the following fields: h4, h6, h10.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the following: 1.Due to various factors such as the shape, numbers, hardness of the calculus, a force beyond the strength resistance was applied to the device during the lithotripsy.2.Due to in state of ¿1¿ description, the coil sheath misalignment occurred.The operating pipe was broken at the brazing joint.3.The lithotripsy was kept on going by combing emergency lithotripter and the subject device.However, a force beyond the strength resistance was applied to the operating wire due to various factors such as the shape, numbers, hardness of the calculus.4.Due to in state of ¿4¿ description, the operating wire was broken and missing.5.3 and 4 were repeated, and the basket was deformed.The instructions for use (ifu) states the following: ·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 type of damage shown in chapter 5, ¿emergency treatment¿ may occur.Use this instrument with the consideration that the instrument may be damaged, 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, tube sheath not completely retracted in coil sheath etc.).Stop use when any abnormality is detected.Olympus will continue to monitor the field performance of the 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: 13008135
• MDR Text Key: 285999815
• Report Number: 8010047-2021-16165
• 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: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

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: 03K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 06/02/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• 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 Q189V, 2618548.
• Patient Outcome(s): Required Intervention