MAUDE Adverse Event Report: STORZ MEDICAL AG MODULITH SLX-F2 180MM (25K) LITHOTRIPTOR; 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	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was treated for 17mm stone in the right kidney mid-pole with 2506 shocks at highest energy level of 7.It is reported that at the time of treatment, there were no issues with the lithotripsy equipment.Device was evaluated onsite on march 17, 2021.No issues were found; device tested within specifications, and device was returned to the customer for use.Hematomas are a known side-effect of eswl treatment.
Event or Problem Description
The customer reported that a patient presented with a hematoma following eswl treatment on (b)(6) 2021.The patient was admitted to the hospital on (b)(6) 2021 and was discharged in stable condition on (b)(6) 2021.

• Brand Name: MODULITH SLX-F2 180MM (25K) LITHOTRIPTOR
• Common Device Name: LITHOTRIPTOR,
• Manufacturer (Section D): STORZ MEDICAL AG; lohstampfestrasse 8; tägerwilen, 8274 ; SZ 8274
• MDR Report Key: 11565737
• Report Number: 9613347-2021-00032
• Device Sequence Number: 4497170
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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: 03/16/2021
• Initial Report FDA Received Date: 03/24/2021
• 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: 67 YR