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

Model Number	29000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device was found to be functional withing the manufacture specifications.Hematoma are know side effect of eswl.
Event or Problem Description
Post eswl treatment, patient complained of pain.

• 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: 24389224
• Report Number: 9613347-2026-00001
• Device Sequence Number: 10622668
• Product Code: LNS
• UDI-Device Identifier: 07630039100919
• UDI-Public: 07630039100919
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: Other
• Device Model Number: 29000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 43 YR
• Patient Sex: Male