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

Catalog Number REF 01-0031

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2021

Event Type  malfunction  

Event Description

When setting up the operating room prior to pt arrival, it was noted on situate console that there was a yellow alert box saying the "accessory" was not functioning.The mat was replaced and the box was then green, meaning it functioned fine, so it was concluded that the issue was with the mat.

• Brand Name: SITUATE
• Type of Device: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11892994
• MDR Text Key: 252916495
• Report Number: 11892994
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF 01-0031
• Device Lot Number: 42OR1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1