MAUDE Adverse Event Report: MEDTRONIC, INC. SITUATE DETECTION SYSTEM; COUNTER, SPONGE, SURGICAL

Model Number 40161543

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2023

Event Type  malfunction  

Event Description

After surgical procedure was completed, surgical team used the situate mat to scan for lap sponges.The unit kept alarming that it "detected" a sponge multiple times.Sponge count was repeated 3 times and all sponges were accounted for.The team then used the situate hand wand and it read "all clear".This was repeated 3 times also.The attending surgeon was in the room and noted device had same issue day prior.

• Brand Name: SITUATE DETECTION SYSTEM
• Type of Device: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 17487211
• MDR Text Key: 320683574
• Report Number: 17487211
• Device Sequence Number: 1
• Product Code: LWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/10/2023

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
• Device Operator: Health Professional
• Device Model Number: 40161543
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White