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).
Additional Manufacturer Narrative
Service report so-(b)(4) was submitted by the dmta field service engineer following the evaluation of the suspect device on 23 feb 2026.The technical safety system checks were all in compliance with dornier specifications.An analysis of complaints determined that there is not an identifiable trend.Patient hematomas are listed as a possible adverse effect and complication in the compact sigma operating manual.The results of this investigation do not indicate any defects or inconsistencies with the suspect device that would impact the functional capacity of the unit.The dhr review indicates the product was manufactured according to specification and the on-site evaluation indicates that the device is functioning as expected.

• 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: 24570867
• Report Number: 1037955-2026-00007
• Device Sequence Number: 9506896
• Product Code: LNS
• UDI-Device Identifier: 04049957000011
• UDI-Public: (01)04049957000011
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/10/2026
• Report Date (Section F): 03/10/2026

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: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• 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: 03/10/2026