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	09/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Minor symptomatic hematoma was reported by the patient to the hospital on (b)(6) 2026 following eswl treatment (b)(6) 2026.The patient was admitted to the hospital for observation.Patient was haemodynamically stable.The patient was discharged from the hospital on (b)(6) 2026.No comorbidities or concomitant medications that could increase the risk of bleeding were reported.
Additional Manufacturer Narrative
This device was found to be functional within the manufacture specifications.Hematoma are known side effect of eswl.

• 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 ; +1(678)581-7255
• MDR Report Key: 50945097
• Report Number: 9613347-2026-00005
• Device Sequence Number: 18525192
• Product Code: LNS
• UDI-Device Identifier: 07630039100919
• UDI-Public: 07630039100919
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Health Professional
• Device Model Number: 29000
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 35 YR
• Patient Sex: Male