MAUDE Adverse Event Report: DORNIER MEDTECH SYSTEMS GMBH COMPACT SIGMA; LITHOTRIPTER

Model Number	COMPACT SIGMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient hematoma was reported to have occured following a procedure utilizing a compact sigma sn (b)(6).

• Brand Name: COMPACT SIGMA
• Common Device Name: LITHOTRIPTER
• Manufacturer (Section D): DORNIER MEDTECH SYSTEMS GMBH; argelsrieder feld 7; wessling, D-822 34; GM D-82234
• MDR Report Key: 22876680
• Report Number: 1037955-2025-00032
• Device Sequence Number: 14891153
• Product Code: LNS
• UDI-Device Identifier: 04049957000011
• UDI-Public: (01)04049957000011
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2025
• Report Date (Section F): 08/22/2025

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: COMPACT SIGMA
• Device Catalogue Number: K1025660
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2025
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2025
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/22/2025