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)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A renal hematoma, meeting the criteria for being serious, occurred after eswl treatment on (b)(6) 2025.The patient was symptomatic and attended a&e the day after eswl with flank pain.Ct was performed which showed the hematoma.Patient was admitted to the hospital for 3 days and was given iv fluids and iv antibiotics.Patient was monitored but remained clinically stable.At discharge the patient was given antibiotics and was asked to return 2 times post treatment for blood tests but was not readmitted.Patient has been asked to follow up the end of (b)(6).
Additional Manufacturer Narrative
The device was found to be functional within the manufacture specifications.Hematoma are known side effect of eswl.

• 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: 22064438
• Report Number: 9613347-2025-00001
• Device Sequence Number: 8478339
• Product Code: LNS
• UDI-Device Identifier: 07630039100919
• UDI-Public: (01)07630039100919(11)201120
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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: 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: 05/01/2025
• Initial Report FDA Received Date: 05/21/2025
• 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: 58 YR
• Patient Sex: Male