MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® HANDPIECE - POWERFORMA®; BUR, EAR, NOSE AND THROAT

Model Number 3327700

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare provider (hcp) reported that the console was getting an error code 2 when using the handpiece during the functional endoscopic sinus surgery procedure.They tried to reboot the console and tried a new handpiece but neither option worked.The procedure was cancelled and the patient was under the anesthesia.There was no patient impact.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare provider confirmed that the adapter to the drill was the one giving them issues.

• Brand Name: XPS® HANDPIECE - POWERFORMA®
• 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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 8148450
• MDR Text Key: 129834125
• Report Number: 1045254-2018-00699
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960853
• 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,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3327700
• Device Catalogue Number: 3327700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 03/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 75