MAUDE Adverse Event Report: STORZ MEDICAL AG MODULITH SLX-F2 180MM 29000; 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	03/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was found to be functional within the manufacture specifications.Hematoma are a known side effect of eswl.
Event or Problem Description
Oem storz medical ag was informed by medical personnel from treating hospital that a patient was diagnosed with hematoma post eswl treatment.Patient admitted for left renal stone treatment was complicated by left acute subcapsular peri-renal hematoma with mass effect (in post operative period).

• Brand Name: MODULITH SLX-F2 180MM 29000
• 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: 16857064
• Report Number: 9613347-2023-00006
• Device Sequence Number: 18274771
• Product Code: LNS
• UDI-Device Identifier: 07630039100919
• UDI-Public: (01)07630039100919(11)211106
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2023

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
• Device Catalogue Number: 29000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2021
• 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: Female