MAUDE Adverse Event Report: DORNIER MEDTECH GMBH DORNIER COMPACT SIGMA

Model Number	K1025660
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 and initially reported to fda under 1037955-2023-00043 on (b)(6) 2023.
Additional Manufacturer Narrative
This complaint was documented subsequent to the inital 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, at 23rd october 2023, concluded that the device was in compliance with dornier specifications.Patient hematoma is listed as a potential adverse effect and complication in the compact sigma operating manual.Details concerning the patient outside of the confirmation of 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 manufacturing and functioning within dornier specifications.

• Brand Name: DORNIER COMPACT SIGMA
• Common Device Name: SIGMA
• Manufacturer (Section D): DORNIER MEDTECH GMBH; argelsrieder feld 7; wessling, bavaria 82234 ; GM 82234
• Manufacturer (Section G): DORNIER MEDTECH GMBH; argelsrieder feld 7; wessling, bavaria 82234 ; GM 82234
• Manufacturer Contact: stefan lutzenberger ; argelsrieder feld 7; wessling, bavaria 82234 ; GM 82234
• MDR Report Key: 18316367
• Report Number: 9611388-2023-00028
• Device Sequence Number: 6784565
• Product Code: LNS
• UDI-Device Identifier: 04049957000011
• UDI-Public: 0104049957000011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K002929N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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: K1025660
• Device Catalogue Number: K1025660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown