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

Model Number	1882940HR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that the blade had came apart once it was used during functional endoscopic sinus surgery (fess).The o-ring came off completely and got stuck in the handpiece but it was also retrieved.There was no delay in the surgical procedure and a back-up device was used and it functioned fine.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that visually, the inner green seal was in place and in good condition when received.Functionally, the blade was loaded in and out of a handpiece 10 times and the seal did not come out of its seated position.There are no signs of a defect with the device.If information is provided in the future, a supplemental report will be issued.

• 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: 7996638
• Report Number: 1045254-2018-00535
• Device Sequence Number: 11109133
• Product Code: EQJ
• UDI-Device Identifier: 00885074079813
• UDI-Public: 00885074079813
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 07/24/2022
• Device Model Number: 1882940HR
• Device Catalogue Number: 1882940HR
• Device Lot Number: HG2PNH2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 86