MAUDE Adverse Event Report: MEDTRONIC INC XOMED HYDRODEBRIDER HANDPIECE ENDOSCOPIC SINUS IRRIGATION SYSTEM; JET LAVAGE

Catalog Number 1914001

Device Problems Device Inoperable (1663); Component Missing (2306)

Patient Problem No Information (3190)

Event Date 01/28/2016

Event Type  malfunction  

Event Description

When hydrodebrider opened, it was missing a piece during the manufacturing that meant it could not be used.Hydrodebrider taken off the field.New hydrodebrider opened.New hydrodebrider fully functioning.

• Brand Name: XOMED HYDRODEBRIDER HANDPIECE ENDOSCOPIC SINUS IRRIGATION SYSTEM
• Type of Device: JET LAVAGE
• Manufacturer (Section D): MEDTRONIC INC; 7611 northland drive; minneapolis MN 55428
• MDR Report Key: 5418636
• MDR Text Key: 37727857
• Report Number: 5418636
• Device Sequence Number: 1
• Product Code: FQH
• 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: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 1914001
• Device Lot Number: 029989521
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR