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	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was found to be functional within the manufacture specifications.
Event or Problem Description
Healthcare provider reported a hematoma occurred around a year ago post eswl.The patient involved then consulted another medical doctor who advised that the kidney should be removed.Manufacturer is unable to confirm that the patient has received a nephrectomy.Repeated attempts to collect more information have been unsuccessful.This event was reported to the manufacturer on 4/25/2025.

• 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: 22071945
• Report Number: 9613347-2025-00002
• Device Sequence Number: 13086736
• Product Code: LNS
• UDI-Device Identifier: 07630039100919
• UDI-Public: (01)07630039100919(11)221111
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 04/25/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown