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

Model Number 1884040RTC

Device Problems Break (1069); Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare professional (hcp) reported that the handpiece was noisy and irrigation seemed slow while the bur quality was inferior and was damaged during the functional endoscopic sinus surgery revision procedure.There were no broken pieces remain inside the patient's body.There was no intervention planned or performed.There was no delay with the procedure.The procedure was completed with backup product.There was no patient impact.

Manufacturer Narrative

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

Event Description

Additional information received mentioned that the bur sounded noisy and did not drill as the surgeon was expecting.

• 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: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 9086572
• MDR Text Key: 159146291
• Report Number: 1045254-2019-00465
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00643169434592
• UDI-Public: 00643169434592
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884040RTC
• Device Catalogue Number: 1884040RTC
• Device Lot Number: 0216860075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 11/05/2019
• 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