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

Model Number 01-0031

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, the body scanner detected but nothing from the mat.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, the device gave a false positive detection.It gave a detection with no tagged sponges present.Another device was used and it worked fine.There was no patient injury.

• Brand Name: SITUATE
• Type of Device: 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9788216
• MDR Text Key: 182204493
• Report Number: 1717344-2020-00250
• Device Sequence Number: 1
• Product Code: LWH
• UDI-Device Identifier: 10884521700642
• UDI-Public: 10884521700642
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1