COMPACT SIGMA
Received Mar 11, 2026
Report 1037955-2026-00007 · MDR key 24570867
Device
Generic name
Lithotripter
Manufacturer
Dornier Medtech Systems GmbhModel number
COMPACT SIGMACatalog number
K1025660
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hematoma
Narrative
Description of Event or Problem
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.