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

Model Number	FR-284
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Trilogy probe attached and worked initially and then few seconds into it the probe was not recognized as attached not allowing matching to work.New probe had to be opened and worked without issue.
Event or Problem Description
Trilogy probe attached and worked initially and then few seconds into it the probe was not recognized as attached not allowing matching to work.New probe had to be opened and worked without issue.
Event or Problem Description
Trilogy probe attached and worked initially and then few seconds into it the probe was not recognized as attached not allowing matching to work.New probe had to be opened and worked without issue.
Event or Problem Description
Trilogy probe attached and worked initially and then few seconds into it the probe was not recognized as attached not allowing matching to work.New probe had to be opened and worked without issue.

• Brand Name: LITHOCLAST
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; 11886 greenville ave., ste 120; ste 120; dallas TX 75243
• MDR Report Key: 19536589
• Report Number: 19536589
• Device Sequence Number: 17685057
• Product Code: FEO
• UDI-Device Identifier: 07613353162603
• UDI-Public: (01)07613353162603
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024
• Report Date (Section F): 03/14/2024
• 2 Devices were Involved in the Event: 1 2

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-284
• Device Catalogue Number: M0068402940
• Device Lot Number: 203942A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/14/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 06/18/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Female
• Date Report Sent to FDA: 03/14/2024