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

Model Number 1882040HR

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A health care provider (hcp) reported that the blade broke during an endoscopic sinus surgery (ess) procedure.The hcp noted that it was the second blade that was broken following the previous week.There was about 15 minutes delay in the procedure but there was no intervention planned or performed.There was no broken pieces remained inside the patient's body.The blade was not used and forceps and so on were used instead.The patient was alive with no injury.

Manufacturer Narrative

Analysis found that the inner cutter tip was broken off.The portion that broke off was not returned however it would have measured approximately 0.09¿ long.There was deformation of the outer tube cutting edge.The damage to the cutting edge matched up to a 0.025¿ diameter reserve sample stylette that is typically included with the blade.The complaint sample stylette was not returned.If information is provided in the future, a supplemental report will be issued.

Event Description

On follow-up, it was reported that the blade was used in submucosal turbinectomy and there was no any additional action taken to prevent patient impact.Although blade fragments were collected, there was about 15 minutes delay in the procedure.The blade was used many times.

• 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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 8175560
• MDR Text Key: 130981683
• Report Number: 1045254-2018-00718
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

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: 08/03/2022
• Device Model Number: 1882040HR
• Device Catalogue Number: 1882040HR
• Device Lot Number: HG2Q902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2018
• 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