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

Model Number 1884380HRE

Device Problem Vibration (1674)

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

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A health care provider reported via manufacturer representative that during a functional endoscopic sinus surgery, the hcp noted she felt the blade was a little bit wobbly and not as stiff as it usually is.She discontinued use of the blade.The procedure was completed with backup product(s).There was no intervention performed.There was 15 minutes delay.There was no patient injury.On follow up, it was reported that the blade was being used on the patient when the event occurred.

Manufacturer Narrative

H3: analysis found that functionally, both inner and middle assemblies would rotate freely.The blade was placed into a handpiece with no issues with fitment.The settings were placed on 7,500 rpm in oscillating mode.During use, the blade exhibited little to no v ibration/wobble.H6: the fdm b17 and fdr c20 no longer applies.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 12115543
• MDR Text Key: 259984469
• Report Number: 9612501-2021-01097
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00763000033910
• UDI-Public: 00763000033910
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884380HRE
• Device Catalogue Number: 1884380HRE
• Device Lot Number: 0221791811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1