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

Model Number 1883519HR

Device Problems Material Separation (1562); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare provider (hcp) reported via a manufacturer representative that the blade was not functioning as expected during the procedure.Upon inspection, the hcp noticed that the inner cannula was detached from the outer cannula.It was noted that there was no broken pieces left inside the patient's body.There was a 5-minute delay in the procedure and the case was completed with a back-up device.The patient was alive with no injury.

• Brand Name: XPS® 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: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 8618208
• MDR Text Key: 145482237
• Report Number: 1045254-2019-00242
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00885074080659
• UDI-Public: 00885074080659
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1883519HR
• Device Catalogue Number: 1883519HR
• Device Lot Number: HG2ZX73
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2019
• 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