MAUDE Adverse Event Report: STORZ MEDICAL AG MODULITH SLX-F2 180MM (25K) LITHOTRIPTOR

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	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a customer follow-up call on (b)(6) 2019, the facility mentioned that few patients had suffered some degree of injury on lithotripter serial number (b)(4).We subsequently learned that two patients presented with hematomas post-treatment and were hospitalized, and both patients required a transfusion; this medwatch report pertains to the second of the two events.The patient was hospitalized on (b)(6) 2019 and was discharged on (b)(6) 2019.The unit recently received preventive maintenance on (b)(6) 2019 and performance was verified with no errors.Hematomas are a known side effect of lithotripsy, which is addressed in our ifu.
Event or Problem Description
Allegedly, the patient presented with a hematoma following an extracorporeal shock wave lithotripsy procedure on (b)(6) 2019.The patient was admitted that day and was transfused.The patient was discharged on (b)(6) 2019.

• Brand Name: MODULITH SLX-F2 180MM (25K) LITHOTRIPTOR
• Common Device Name: LITHOTRIPTOR
• Manufacturer (Section D): STORZ MEDICAL AG; untereseestrasse 47; kreuzlingen ch-8280, ; SZ
• MDR Report Key: 8962893
• Report Number: 9613347-2019-00078
• Device Sequence Number: 16816355
• Product Code: LNS
• UDI-Device Identifier: 07630039100230
• UDI-Public: 7630039100230
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K072788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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
• Device Catalogue Number: 25000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR