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

Model Number BML-V232QR-30

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

Patient Problem No Code Available (3191)

Event Date 02/20/2015

Event Type  Injury  

Manufacturer Narrative

The subject product was not returned to omsc.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 was detected.Omsc considers that the calculus was too hard to crush.The device instruction manual has warned users that there is possibility the stone cannot be crushed by lithotriptor, and it also describes what to do if the lithotriptor cannot crush stone.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus medical system corp.(omsc) was informed that the doctor attempted to crush stone 4 centimeters in size with the subject device but he couldn't.The device did not break.The doctor abandoned the procedure and cut the device.The stone and device were removed from the patient by surgery.The patient remained in the hospital after surgery and was discharged on march 5.

• Brand Name: OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP.; 2951; ishikawa-cho,; hachioji-shi, tokyo 192-8 502; JA 192-8502
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 5024241
• MDR Text Key: 23797249
• Report Number: 8010047-2015-00691
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Report Date: 07/16/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: BML-V232QR-30
• Device Lot Number: 47K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention