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

Model Number 01-0043

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

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 the procedure, the device had a detection three times and then was clear two times.The wound was never re-opened or explored.The circulator said it was detecting in the same exact spot each time.There were no sponge and or laps anywhere close to the area.The staff completed multiple counts to ensure there was no sponge left behind.There was no patient injury.

Manufacturer Narrative

Evaluation summary: the returned sample met specification as received by medtronic.The visual inspection found no visible ferrite core.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.No corrective action is required, because no reported event was identified, since the product tested satisfactory.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure, the device had a detection 3 times and then was clear 2 times.The wound was never re-opened or explored.The circulator said it was detecting in the same exact spot each time.There were no sponge and or laps anywhere close to the area.The staff completed multiple counts to ensure there was no sponge left behind.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: 9446261
• MDR Text Key: 170117176
• Report Number: 1717344-2019-01609
• Device Sequence Number: 1
• Product Code: LWH
• UDI-Device Identifier: 10884521700703
• UDI-Public: 10884521700703
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-0043
• Device Catalogue Number: 01-0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2019
• 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