COMPACT SIGMA
Received Jun 9, 2026
Report 9611388-2026-00006 · MDR key 25439478
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hematoma
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT WAS DOCUMENTED SUBSEQUENT TO THE INITIAL REPORTING. A SERVICE REPORT WAS COMPLETED BY DMTA FIELD SERVICE ENGINEER FOLLOWING THE EVALUATION OF THE DEVICE IDENTIFIED BY THIS COMPLAINT. THIS TECHNICAL SYSTEM SAFETY CHECK WAS CONDUCTED AT 12 MAY 2026 AND CONCLUDED THAT THE DEVICE WAS IN COMPLIANCE WITH DORNIER SPECIFICATION. PATIENT HEMATOMA IS LISTED AS POTENTIAL ADVERSE EFFECT AND COMPLICATION IN THE SIGMA OPERATING MANUAL. DETAILS CONCERNING THE PATIENT OUTSIDE OF THE CONFIRMATION OF THE HEMATOMA WERE NOT PROVIDED TO DMTA FOR REVIEW. THE RESULT OF THIS INVESTIGATION REVEALED NO DEFECTS OR INCONSISTENCIES WITH THE IDENTIFIED DEVICE. THE REVIEWS CONDUCTED FOR THIS INVESTIGATION CONCLUDED THE DEVICE WAS MANUFACTURED AND FUNCTIONING WITHIN DORNIER SPECIFICATIONS.
Description of Event or Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2026-00018 ON (B)(6) 2026.
Remedial action
- Other