MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS QUADCUT BLADE; BUR, EAR, NOSE (BLADE)

Catalog Number 1884380HR

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2016

Event Type  malfunction  

Event Description

When using the shaver handpiece during a case after hooking it up, it was working just fine and then about 30 minutes into the case, there was saline leakage noted coming from the shaver handpiece and where it hooks up to the blade.Upon inspection, the shaver blade was separated into two pieces.Switched shaver handpieces and had same issues.Switched to a new blade with the original handpiece and it worked great.The drape got slightly wet from the leak but the patient was not harmed by the defective blade.

• Brand Name: QUADCUT BLADE
• Type of Device: BUR, EAR, NOSE (BLADE)
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st.; fort worth TX 76137
• MDR Report Key: 5737717
• MDR Text Key: 47811640
• Report Number: 5737717
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2016

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: Physician
• Device Expiration Date: 01/10/2020
• Device Catalogue Number: 1884380HR
• Device Lot Number: 0210656191
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR