MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. XPS BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1882940HR

Device Problem Suction Problem (2170)

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

Event Date 10/12/2017

Event Type  malfunction  

Event Description

Ent surgeon was using a 2.9mm turbinate blade to reduce patient's turbinates, but the suction function of the instrument was not working.All measures were taken to ensure that the equipment was correctly connected.When a faulty connection was ruled out, another blade was opened and found to be working properly.Manufacturer response for inferior turbinate blade, 11cm x 2.9mm turbinate blade (per site reporter): none as of today.

• Brand Name: XPS BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint dr. north; jax FL 32216
• MDR Report Key: 6990066
• MDR Text Key: 90669129
• Report Number: 6990066
• Device Sequence Number: 1
• Product Code: EQJ
• 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: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1882940HR
• Device Catalogue Number: 1882940HR
• Other Device ID Number: BLADE 1882940HR 5PK M4 INF TU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 32 YR