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

Model Number	BML-V242QR-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of our investigation, the user facility was contacted to obtain additional information regarding the reported event and was informed that the lithotripter will not be returned for evaluation as it was discarded by the facility.The cause of the reported event cannot be determined at this time.
Event or Problem Description
The service center was informed that during an endoscopic retrograde cholangiopancreatography (ercp) procedure, the lithotripter wire was cut 20 cm from the impacted and retained gall stone.The customer reported that multiple maneuvers were performed to remove the basket, but were unsuccessful.A new lithotripter was used to remove the basket and finish the procedure.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint.The lm reported that the cause of the event could not be conclusively determined.The legal manufacturer reported that the most likely probable causes 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.The device history record for the lot indicated no anomaly with the event-related items below.Process inspection sheet.Quality inspection sheet.Nonconforming product report.The legal manufacturer reported that the instruction manual contains a warning to the user regarding this event.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 pen surgery may have to take place.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.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.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Common Device Name: 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: 10701495
• Report Number: 8010047-2020-07850
• Device Sequence Number: 3174677
• Product Code: LQC
• UDI-Device Identifier: 04953170218392
• UDI-Public: 04953170218392
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: BML-V242QR-30
• Device Lot Number: 8ZK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1