MAUDE Adverse Event Report: Covidien Situate; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	G0404-16P01C-1
Medical Device Problem Codes	Material Frayed (1262); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction

• Brand Name: Situate
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): Covidien; 200 medtronic drive; lafayette,co
• Manufacturer (Section G): Covidien; 200 medtronic drive; lafayette,co
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50938601
• Report Number: 3026612481-2026-00055
• Device Sequence Number: 16136087
• Product Code: GDY
• UDI-Device Identifier: 20884521700601
• UDI-Public: (01)20884521700601(17)310608(10)260619AT
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: G0404-16P01C-1
• Device Catalogue Number: G0404-16P01C-1
• Device Lot Number: 260619AT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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