MAUDE Adverse Event Report: ALLMED INDUSTRIAL LIMITED SITUATE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	G0804-12P02C-1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving gauze; xray; rfd; 8 x 4; 12-ply; strl; lf, a piece or part fell into the patient cavity.The piece was fully retrieved without the need for an x-ray.Additionally, it was noted that pieces of raytec were fraying off.No medical or surgical intervention was needed to prevent a permanent impairment of a function, and there was no injury as a result of the event.
Additional Manufacturer Narrative
D10 concomitant product: g0804-12p02c-1 gauze; xray; rfd; 8x4; 12-ply; strl; lf; 241102at.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SITUATE
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): ALLMED INDUSTRIAL LIMITED; 19f block a taurus plaza; shenzhen 51805 5; CH 518055
• Manufacturer (Section G): ALLMED INDUSTRIAL LIMITED; 19f block a taurus plaza; shenzhen 51805 5; CH 518055
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21767021
• Report Number: 1717344-2025-00470
• Device Sequence Number: 18290452
• Product Code: GDY
• UDI-Device Identifier: 10884521700833
• UDI-Public: 10884521700833
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: G0804-12P02C-1
• Device Catalogue Number: G0804-12P02C-1
• Device Lot Number: 241009AT
• 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: 03/11/2025
• Initial Report FDA Received Date: 04/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES ON H11
• Patient Sex: Unknown