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

Model Number BML-V442QR-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

Olympus medical systems corp (omsc) was informed that during crushing stone, the distal tip of the subject device came off into the common bile duct.The doctor retrieved the tip and completed the procedure.There was no report of the patient injury regarding this report.

Manufacturer Narrative

The subject device was discarded by the user facility.The exact cause of the user's experience could not be conclusively determined.As the checking of the manufacturing record of the same lot, nothing abnormal detected.A supplemental report will be submitted, if additional and significant information becomes available at a later time.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507
• MDR Report Key: 4428342
• MDR Text Key: 5168512
• Report Number: 8010047-2015-00033
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2014

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
• Device Operator: Other
• Device Model Number: BML-V442QR-30
• Device Lot Number: 3ZK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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