MAUDE Adverse Event Report: STORZ MEDICAL AG MODULITH SLX-F2 180MM 25000; LITHOTRIPTER

Model Number	25000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a patient presented with a hematoma following eswl treatment on (b)(6) 2022.Patient was admitted to the hospital but additional information concerning admission and discharge have not been provided by the physician.
Additional Manufacturer Narrative
Physician reported post eswl hematoma requiring hospitalization.Despite multiple requests, no further information is available.The device was found to be functional within the manufacture specifications.Hematoma are known side effects of eswl.

• Brand Name: MODULITH SLX-F2 180MM 25000
• Common Device Name: LITHOTRIPTER
• Manufacturer (Section D): STORZ MEDICAL AG; lohstampfesstrasse 8; taegerwilen, 8274 ; SZ 8274
• Manufacturer (Section G): STORZ MEDICAL AG; lohstampfesstrasse 8; taegerwilen, 8274 ; SZ 8274
• Manufacturer Contact: devonne pavlak ; 1000 cobb place blvd; building 400 suite 450; kennesaw, GA 30144 ; 6785817255
• MDR Report Key: 16855149
• Report Number: 9613347-2022-00002
• Device Sequence Number: 7637376
• 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: K072788
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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: 25000
• 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: 02/24/2022
• Initial Report FDA Received Date: 05/02/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown