MAUDE Adverse Event Report: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. LITHOCLAST; LITHOTRIPTOR, ULTRASONIC

Model Number	FR-305
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The swiss lithoclast trilogy disposable probe kit was used during this case.During the procedure, 1 probe snapped into two pieces, and 1 probe bent.A third probe was opened and used with no issue.

• Brand Name: LITHOCLAST
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; 2150e continental boulevard; southlake TX 76092
• MDR Report Key: 19593150
• Report Number: 19593150
• Device Sequence Number: 12879233
• Product Code: FEO
• UDI-Device Identifier: 07613353123697
• UDI-Public: (01)07613353123697
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/31/2024
• Report Date (Section F): 05/31/2024

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: FR-305
• Device Catalogue Number: M0068403540
• Device Lot Number: 205460A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 05/31/2024