MAUDE Adverse Event Report: COVIDIEN LP SUPERLOCK; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number SDGN447

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2021

Event Type  malfunction  

Event Description

Fiducial markers got stuck in the delivery device during a nav bronch procedure.Two markers got stuck and we wasted an extra delivery kit.The rep was here and we were able to get one marker out of the delivery kit and were able to deploy it.She took the packaging and marker with her to show the company.

• Brand Name: SUPERLOCK
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11146922
• MDR Text Key: 226044762
• Report Number: 11146922
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SDGN447
• Device Catalogue Number: SDGN447
• Device Lot Number: 515620 & 512680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA