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

Model Number 1884380EM

Device Problems Use of Device Problem (1670); Vibration (1674)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis results were not available as of the date of this  report.  a follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by a health care professional (hcp) that the blade was vibrating and slow during use in an endoscopic sinus surgery.Hcp tried a new hand piece and that did not resolve the issue.Hcp switched blade to a new one and it worked normally.The device had contact with the patient.There was no patient impact.

Manufacturer Narrative

H3 the product analysis result indicates that the middle assembly would rotate freely.The inner assembly cutter rotated freely.The blade seated into the handpiece with ease.The blade oscillated in the lab and exhibited a wobble and vibration.The inner blade was removed and spun on a flat raised surface.The hub did not appear to be concentric.Using a concentricity gage the hub was found to be out of concentricity.There was evidence to support improper manufacturing.The information most likely indicates an issue with the manufacturing of the product.H6: additional information suggest that fdm b21 , fdr and c21 fdc d16 are no longer applicable to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information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 SYSTEM NAVIGATED BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 11798584
• MDR Text Key: 249954359
• Report Number: 9612501-2021-00733
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• PMA/PMN Number: K130608
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884380EM
• Device Catalogue Number: 1884380EM
• Device Lot Number: 0221319087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 70