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

Model Number	1884012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation; a product analysis is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the tip was damaged shortly after he began using it.There was no impact to the patient, and a new blade was opened to continue the fess procedure.
Additional Manufacturer Narrative
One opened sample of part number 1884012, from lot number 0214982801 was received for analysis.Visually, there was gouging at the inner and outer assembly distal tips which would have resulted in the reported event.The inner assembly spun, but had a gravely feel, and the outer assembly cutting teeth were bent outward at the points only (the very tip).There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.There was no allegation of a defect prior to use, and although misuse cannot be ruled out as a potential cause, the information more likely indicates the blade inadvertently came in to contact with an inappropriate material.The ifu states ¿the ipc system is a powered microdebrider, drill and saw system that will remove soft tissue, hard tissue and bone during surgical procedures.¿ while bone is considered a relatively hard substance, contact with a surgical tool, scalpel, scope, or other metal device would result in such damage.There was an out of specification condition identified as it relates to the complaint (due to physical damage).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the tip was damaged shortly after he began using it.There was no impact to the patient, and a new blade was opened to continue the fess procedure.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7836115
• Report Number: 1045254-2018-00405
• Device Sequence Number: 19252225
• Product Code: EQJ
• UDI-Device Identifier: 00681490047531
• UDI-Public: 00681490047531
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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 Expiration Date: 02/24/2024
• Device Model Number: 1884012
• Device Catalogue Number: 1884012
• Device Lot Number: 0214982801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1