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

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

The closing count was incorrect.Staff scanned patient with situate mat and received ¿all clear¿ message.Staff then used situate wand on field and a lap pad was detected.The surgeon had a towel towards the head of the bed.Once the towel was lifted, a lap pad was identified and retrieved.Concern that situate mat did not detect lap pad that was detected by situate wand.Manufacturer response for situate mat, situate sponge detection system (per site reporter).They are reviewing/ investigating.

• Brand Name: SITUATE SPONGE DETECTION SYSTEM
• Type of Device: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 16688810
• MDR Text Key: 312808113
• Report Number: 16688810
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Male
• Patient Weight: 26 KG
• Patient Race: White