MAUDE Adverse Event Report: COVIDIEN LLC XPS SYSTEM NAVIGATED BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1884380EM
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were 2 devices used in the surgery and were submitting 2 mdrs for the same event.List of products involve blade 1884380em quadcut 4.3mm x 13cm m4 lot no.221118536 qty: 2 units this is same event as regulatory report # 9612501-2021-01628.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by health care professional that the blades were wobbly during use.They opened a second bur and observed same results.There was no patient impact.The procedure was completed with backup product(s) with 10 minutes delay.

• Brand Name: XPS SYSTEM NAVIGATED BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 12568748
• Report Number: 9612501-2021-01629
• Device Sequence Number: 4094825
• Product Code: EQJ
• UDI-Device Identifier: 00763000034023
• UDI-Public: 00763000034023
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1884380EM
• Device Catalogue Number: 1884380EM
• Device Lot Number: 0221118536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1