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

Model Number 1882923HRE

Device Problem Break (1069)

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

Event Date 10/10/2021

Event Type  malfunction  

Event Description

A health care provider reported that the part nearest to the tip appears broken, the two segments are not solid.No broken pieces of the reported product remain inside the patient's body.Patient is alive and no injury.No known patient impact.

Manufacturer Narrative

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

Event Description

On follow-up it was reported that during a laryngoscopy procedure pieces noticed broken at the tip of the device and removed before patient use.There were no fragments detached from the device.There was a very minimal delay in the surgical procedure and no intervention was planned/performed.They had to open a second device to complete the case.The product was utilized correctly according to the directions given in the ifu/labeling.There was no patient or staff impact.

Manufacturer Narrative

H3: product analysis of the device found that visually, the middle tube was bent distal to the outer sheath which would have resulted in the reported event.There was no damage to the packaging carton.There was no damage to the distal tip.There were no loose components.Functionally, the outer assembly spun freely by hand, but the inner assembly was stuck with the middle assembly and spun in unison - console functional testing was not performed due to this defect.In the returned condition, there was an out of specification condition that was related to the complaint (due to physical damage).H6: previous codes fdm - b17, fdr - c20, fdc - d14 no longer applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by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): 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: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 12834898
• MDR Text Key: 280932989
• Report Number: 1045254-2021-00635
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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: 1882923HRE
• Device Catalogue Number: 1882923HRE
• Device Lot Number: 0222678990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• 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