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	10/14/2022
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 was informed by medical personnel from treating hospital that a patient was diagnosed with hematoma post eswl treatment.No information concerning the patient or their pre and post eswl condition has been forthcoming from the treating physician or facility.The device has been evaluated and no issues were detected.(b)(6) 2022 additional information received: eswl treatment (b)(6) 2022, right kidney stone 5mm at energy level 1.0 - 5.0 for total of 3000 shocks.Patient treated for severe right loin pain, admitted to ward and ct shows right perinephric hematoma with active contrast extravasation up to 4.8cm.Blood pressure borderline, hb dropped from 13.5 to 9.3.

• 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: 16856558
• Report Number: 9613347-2022-00004
• Device Sequence Number: 6564330
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/28/2022

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
• Device Model Number: 29000
• Device Catalogue 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: 10/17/2022
• 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; Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG