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

Model Number 1884380EM

Device Problem Vibration (1674)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

H3: product analysis of the device found that the middle assembly would rotate freely.The inner assembly cutter rotated freely.The blade seated into the handpiece with ease.The blade oscillated and exhibited a wobble and vibration.The hub did not appear to be concentric.There are 4 mdrs being submitted for the same event.Here are the following model number and lot number: product id:1884006em, lot number: 0220659888 product id:1884380em, lot number: not available product id:1884380em, lot number: 0221182518 product id:1884380em, lot number: 0221182518 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.

Event Description

A healthcare professional (hcp) reported that during the functional endoscopic sinus surgery three quadcut blades had chattering (wobbling) issues, removed blades, replaced, tried again but still it was chattering, changed hadpiece but still it was chattering.User changed to a new blade rad40 blade it was not chattering, but it broke at the distal tip while being used on the patient.The tip sprung out as soon as the user put it in the patient and initiated the blade to begin shaving.User used balde from diffirent lot it was not chattering.There was no patient injury.

• Brand Name: XPS® SYSTEM NAVIGATED BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 18361654
• MDR Text Key: 330957406
• Report Number: 9612501-2023-02431
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00763000034023
• UDI-Public: 00763000034023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2023

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 Expiration Date: 11/27/2022
• Device Model Number: 1884380EM
• Device Catalogue Number: 1884380EM
• Device Lot Number: 0221182518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2020
• 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
• Patient Sex: Male