MAUDE Adverse Event Report: STORZ MEDICAL AG MODULITH; LITHOTRIPTER

Model Number	29000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device was found to be functional within the manufacture specifications.Hematoma are known side effect of eswl.Additional information has been requested from the treating physician but has not been received.
Event or Problem Description
Confirmed hematoma post eswl treatment.Treating physician initially reported patient had multiple embolizations and eventually went on to require a nephrectomy.No additional information has been provided, including date of event, additional medical treatment, prognosis.Hematoma are a known side effect of eswl treatment.

• Brand Name: MODULITH
• 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: 22545247
• Report Number: 9613347-2025-00005
• Device Sequence Number: 18296359
• Product Code: LNS
• UDI-Device Identifier: 07630039100230
• UDI-Public: (01)07630039100230(11)190830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K02788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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
• 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: 06/19/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2019
• 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 Sex: Unknown