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

Model Number BML-V442QR-30

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.

Event Description

A report was received by the service center that a single use mechanical lithotriptor v basket (bml-v442qr-30) lot number 92k, became stuck during a procedure.The physician was performing a lithotripsy and using the device to crush the stones when the lithotriptor basket became stuck.The physician was unable to retrieve the basket using the emergency lithotripter handle to remove the basket.An unspecified intervention protocol had to be implemented to retrieve the basket.It was reported there was no patient harm.

• 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: 9660862
• MDR Text Key: 221017199
• Report Number: 8010047-2020-01081
• 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: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• 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: 92K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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