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

Model Number 1884380EM

Device Problem Vibration (1674)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

There were 2 devices used in the surgery and we're submitting 2 mdrs for the same event list of products involved: blade 1884380em quadcut 4.3mm x 13cm m4 lot# no information blade 1884380em quadcut 4.3mm x 13cm m4 lot# no information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the health care professional that the blades were vibrating excessively during endoscopic sinus surgery.There was no patient impact.The procedure was completed by a back up device and had 5 minutes delay.The devices had contact with the patient.On follow up it was reported that the vibrating devices were used initially and then they opened another blade to finish the case successfully.

• Brand Name: XPS SYSTEM NAVIGATED BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: david gustafson ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635149628
• MDR Report Key: 12092119
• MDR Text Key: 259617386
• Report Number: 1045254-2021-00332
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884380EM
• Device Catalogue Number: 1884380EM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1