MAUDE Adverse Event Report: COVIDIEN LLC EDGE CATHETER SYSTEM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number KIT190 CATHETER

Device Problems Break (1069); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2017

Event Type  malfunction  

Event Description

Equipment was rendered inoperable due to a broken plastic tab disabling device for use during navigational bronchoscopy.

• Brand Name: EDGE CATHETER SYSTEM
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 6568749
• MDR Text Key: 75258581
• Report Number: 6568749
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2017

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: Physician
• Device Expiration Date: 10/28/2019
• Device Model Number: KIT190 CATHETER
• Device Lot Number: EK06321
• Other Device ID Number: SDK4190-FT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLIACBLE
• Patient Age: 69 YR