MAUDE Adverse Event Report: EUROMI S.A. EUROMI; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	3G - ASPIRATION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, the cannula broke at the base during use.No clinical consequences were reported for the patient, and no injury, clinical signs or symptoms, additional medical intervention, hospitalization, prolonged procedure or permanent impairment were reported.The complaint was received on 15-sep-2026.The affected device could not be returned for evaluation; photographs of the broken cannula were provided.The device was replaced under warranty.The event is being reported as a device malfunction because the breakage represents a failure of the device during use and, in accordance with the manufacturer's mdr assessment, the malfunction is considered reportable to fda.
Additional Manufacturer Narrative
The complaint was confirmed based on the photographic evidence showing breakage of the cannula at the base.The affected device was not returned and therefore could not be physically evaluated.The manufacturer's review of the available traceability and manufacturing records did not identify any manufacturing anomaly or recurrent issue.Based on the available information, the breakage may be associated with excessive mechanical stress applied during the procedure.The associated risk is known and documented in the risk management file and ifu.No corrective or preventive action was considered necessary.The event will continue to be monitored through post-market surveillance for any recurrence of similar complaints.

• Brand Name: EUROMI
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): EUROMI S.A.; 11 rue des nouvelles technolog; z.i. des plenesses; andrimont, liege 4821 ; BE 4821
• Manufacturer (Section G): EUROMI; avenue de la solette; sailly lez cambrai, nord 59554 ; FR 59554
• Manufacturer Contact: lauraleen thorez ; 11 rue des nouvelles technologies; andrimont, liege 4821 ; BE 4821
• MDR Report Key: 50912170
• Report Number: 3007697975-2026-00001
• Device Sequence Number: 20278210
• Product Code: GEA
• UDI-Device Identifier: 03701416203319
• UDI-Public: 03701416203319
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3G - ASPIRATION
• Device Catalogue Number: 1214L3GI-3350
• Device Lot Number: 25BRGI305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown