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

Model Number	BML-110A-1
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to the service center for evaluation, therefore, the cause of the reported event could not be determined at this time.To mitigate the risk of patient injury or device damage, the instruction manual provides warning that states, "before use, carefully inspect the entire coil sheath as instructed in this chapter; confirm that it is not crushed, bent, deformed or otherwise damaged.A damaged coil sheath may not be able to properly crush a calculus and/or it could cause the instrument to break.".Additionally, "do not use this lithotriptor bml-110a-1 for a calculus that is assumed impossible to be crushed by this lithotriptor.The basket wire etc.May break and part of this lithotriptor may remain in the body.".
Event or Problem Description
The manufacturer was informed that during a procedure the device became stuck in the patient's bile duct area.The doctor reported that the attached handle was cut off from the basket wire and attached the emergency handle.Instead, since the doctor is on a fluoroscopy with the patient so the doctor could view in real time on what is going on at the trouble area.The doctor was able to crush the stuck stone from the area and withdraw the whole wire basket from the patient.There was no additional surgery required.There was no serious injury reported.

• Brand Name: MECHANICAL LITHOTRIPTOR
• Common Device Name: 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: 9304492
• Report Number: 8010047-2019-03922
• Device Sequence Number: 19333692
• Product Code: LQC
• UDI-Device Identifier: 04953170033001
• UDI-Public: 04953170033001
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K903529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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-110A-1
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1