MAUDE Adverse Event Report: Medtronic Grand Rapids Medtronic Mini Sucker; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTAB

Model Number	10062
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction

• Brand Name: Medtronic Mini Sucker
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTAB
• Manufacturer (Section D): Medtronic Grand Rapids; 620 watson sw; grand rapids MI 49504
• Manufacturer (Section G): Medtronic Grand Rapids; 620 watson sw; grand rapids MI 49504
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50537757
• Report Number: 3003955307-2026-00241
• Device Sequence Number: 6051275
• Product Code: GCY
• UDI-Device Identifier: 00613994570482
• UDI-Public: (01)00613994570482(17)290519(10)0233872341
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K950754
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 10062
• Device Catalogue Number: 10062
• Device Lot Number: 0233872341
• 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: 08/04/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown