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

Model Number 1882040

Device Problems Use of Device Problem (1670); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis of the blade found the green seal in the inner hub was in place and in good condition.The inner tip was broken off.The tip was not returned; however, the portion that became detached would have measured approximately 0.07¿ long x 0.06¿ diameter.There was minor wear on the inner shaft 1.00¿ from the distal face of the inner hub, which corresponds to the junction between the outer tube and front hub.There was deformation of the outer tube cutting edge; however, there was a radial indent at the distal most end.There were scratches on the returned stylet.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional (hcp) reported via a manufacturer representative that the blade was not suctioning during the operation.T he blade was used normally and a cleaner brush was used to unclog the tube.There was no patient impact.

• 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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7899505
• MDR Text Key: 121441958
• Report Number: 1045254-2018-00452
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00681490613286
• UDI-Public: 00681490613286
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1882040
• Device Catalogue Number: 1882040
• Device Lot Number: 0214921934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• 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