MAUDE Adverse Event Report: COVIDIEN LP/ MEDTRONIC SITUATE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number L0418-04P01C-1

Device Problems Product Quality Problem (1506); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

Laparotomy sponge (raytec) was placed in patient's shoulder intraoperatively.During surgery, sponge was accidentally nicked, and battery fell out of sponge into shoulder.Item was removed.Staff concerns with the integrity of the sponge.

• Brand Name: SITUATE
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN LP/ MEDTRONIC; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 14218298
• MDR Text Key: 290178307
• Report Number: 14218298
• Device Sequence Number: 1
• Product Code: GDY
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: L0418-04P01C-1
• Device Catalogue Number: L0418-04P01C-1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2022
• Date Report to Manufacturer: 04/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA