MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS LITHOTRIPTSY PROBE; LITHOTRIPTOR, ULTRASONIC

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

Lithotripter probe failed to operate at optimal perimeters.Surgeon noticed probe bent, upon retrieval outside of the patient the probe broke in half.New probe attained, procedure completed as planned.Fda safety report id# (b)(4).

• Brand Name: LITHOTRIPTSY PROBE
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 12953891
• MDR Text Key: 281938919
• Report Number: MW5105869
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female