MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - IPC® M5 AND M4 30K; BUR, EAR, NOSE AND THROAT

Model Number XOM UNK 30KBUR

Device Problems Inability to Irrigate (1337); Overheating of Device (1437)

Patient Problems Abrasion (1689); Burn(s) (1757)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

3 of 4.If information is provided in the future, a supplemental report will be issued.

Event Description

A health care provider (hcp) reported that the irrigation was not working well on the console during the functional endoscopic sinus surgery.The bur was used to drill on the frontal bone.They tried to change the irrigation; however, they were not able to change it on the console.The irrigation was set to 20.All 4 burs had the irrigation issue as the irrigation was not able to be changed.There was no delay in the procedure and the case was completed.The touchscreen was reprogrammed by the rep and the irrigation buttons were working properly already.They noticed a minor abrasion/burn on the patient's nostril.

• Brand Name: XPS® BUR - IPC® M5 AND M4 30K
• 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: 8071322
• MDR Text Key: 127368630
• Report Number: 1045254-2018-00597
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XOM UNK 30KBUR
• Device Catalogue Number: XOM UNK 30KBUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2018
• 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
• Patient Age: 70 YR
• Patient Weight: 83