MAUDE Adverse Event Report: STORZ MEDICAL AG MODULITH SLX-F2; LITHOTRIPTER

Model Number	25000
Medical Device Problem Codes	Misfocusing (1401); Use of Device Problem (1670)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hematoma are known side effect of eswl.Focal point check (7.2 in maintenance record) did not pass.For targeted shockwave application, proper alignment between lithotripter and x-ray system is required.The user is thus advised (training/ifu) to perform a focus check daily before treatment.The ifu also states that "no treatment is allowed to be performed if the reflection mark is not within the specified area.Inform your service centre." we did ask the user if they had followed our instructions and they said they would usually perform the focus check tri-monthly as part of their qa.According to the user, the last qa was performed on 9.9.25, i.E., after the occurrence of the first reported hematoma and before the remaining two hematomas.The hospital/user of the device has been reminded to perform all relevant function checks as per our instructions.Misalignment has been corrected and device was put back into service.
Event or Problem Description
Post eswl treatment, ct scan confirmed large subcapsular hematoma, no active bleed.Admitted with pain, blood pressure drop, no active bleed, no transfusion.

• Brand Name: MODULITH SLX-F2
• Common Device Name: LITHOTRIPTER
• Manufacturer (Section D): STORZ MEDICAL AG; lohstampfestrasse 8; taegerwilen, 8274 che ; SZ
• Manufacturer (Section G): STORZ MEDICAL AG; lohstampfestrasse 8; taegerwilen, 8274 che ; SZ
• Manufacturer Contact: devonne pavlak ; 1000 cobb place blvd.; building 400 suite 450; kennesaw, GA 30144 ; 6785817255
• MDR Report Key: 23486491
• Report Number: 9613347-2025-00008
• Device Sequence Number: 10329791
• Product Code: LNS
• UDI-Device Identifier: 07630039100230
• UDI-Public: 07630039100230
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: 25000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2015
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male