MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® SYSTEM NAVIGATED BLADE; INSTRUMENT, STEREOTAXIC

Model Number	1884006EM
Medical Device Problem Codes	Material Separation (1562); Obstruction of Flow (2423)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.  a follow-up report will be submitted when analysis is complete.  if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) via manufacturer representative reported that during functional endoscopic sinus surgery, a blade kept getting clogged and was cleared multiple times with a stylet.The surgeon removed tip and inserted stylet from hind end to clear blade.The blade was replaced on the handpiece and used in the right nasal cavity.Blade stopped working and upon removal it was noticed that the tip was missing and a spring was showing.The surgeon used a 30 degree scope to locate the blade tip cover in the cavity.An x-ray confirmed absence of any foreign bodies.There was a delay in the surgical procedure of less than 1 hour.
Additional Manufacturer Narrative
Analysis found that the returned blade had separated and broke off at the tip.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® SYSTEM NAVIGATED BLADE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8537494
• Report Number: 1045254-2019-00203
• Device Sequence Number: 14064356
• Product Code: HAW
• UDI-Device Identifier: 00613994617408
• UDI-Public: 00613994617408
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2020
• Device Model Number: 1884006EM
• Device Catalogue Number: 1884006EM
• Device Lot Number: 0216733804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 YR
• Patient Weight: 91