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

Model Number XOM UNK BUR

Device Problems Material Separation (1562); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

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 bur broke in two, the root part of the bur remained and did not detached from the handpiece and the other came off during the ess (endoscopic sinus surgery) procedure.The detached piece seemed to be caught by hospital staff.So, there were no fragments fallen into neither the operating field nor the non-operative field.There was no fragments that got in contact with the patient.There was no troubleshooting done.There was another handpiece that was owned by the hospital and they used it to complete the procedure.There was no impact on neither the patient nor the staff.

• Brand Name: XPS BUR - UNKNOWN
• 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: david gustafson ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635149628
• MDR Report Key: 12377387
• MDR Text Key: 268465539
• Report Number: 1045254-2021-00483
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2021

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: XOM UNK BUR
• Device Catalogue Number: XOM UNK BUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 08/27/2021
• 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