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

Model Number	FR-286
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As we were using the product, it broke in half.Both pieces were removed from the field.

• Brand Name: LITHOCLAST
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; 2150 e continental blvd; southlake TX 76092
• MDR Report Key: 20577450
• Report Number: 20577450
• Device Sequence Number: 8226804
• Product Code: FEO
• UDI-Device Identifier: 07613353162627
• UDI-Public: (01)07613353162627
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/29/2024
• Report Date (Section F): 08/29/2024

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-286
• Device Catalogue Number: M0068402920
• Device Lot Number: 210183A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Date Report Sent to FDA: 08/29/2024