MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SITUATE; COUNTER, SPONGE, SURGICAL

Model Number	01-0031
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: 01-0043, console; model 200x, (sn: (b)(6)) 01-0046, 01-0046 blair port wand x, (sn: (b)(6)).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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during procedure, as surgery was being wrapped-up, the scanning devices was kept getting flip-flopped results of clear vs detection as something between the mat and wand was coming up unclear.Mat was saying "detection" and wand was not detecting anything.They needed to order an x-ray to determine final diagnostics.X-ray was negative.There was unnecessary radiation due to prolonged use of product.
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during procedure, as surgery was being wrapped-up the scanning devices was kept getting flip-flopped results of clear vs detection, as something between the mat and wand was coming up unclear.Mat was saying "detection" and wand was not detecting anything.They needed to order an x-ray to determine final diagnostics.X-ray was negative.There was unnecessary radiation due to prolonged use of product.The mat was plugged in with the representative on side the mat failed immediately upon the console turning on.

• Brand Name: SITUATE
• Common Device Name: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21191519
• Report Number: 1717344-2025-00157
• Device Sequence Number: 3467563
• Product Code: LWH
• UDI-Device Identifier: 10884521700642
• UDI-Public: 10884521700642
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 02/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01-0031
• Device Catalogue Number: 01-0031
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 02/13/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown