MAUDE Adverse Event Report: MEDTRONICS VAUGHAN SINUS SUCTION MUSHROOM POUCH

Model Number MCEN118

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

During sinus surgery the mushroom punch from sinus accessory set broke off in patient's sinus.Noted on removal from the nose, and surgeon was able to retrieve the broken piece.

• Brand Name: VAUGHAN SINUS SUCTION MUSHROOM POUCH
• Type of Device: SINUS SUCTION
• Manufacturer (Section D): MEDTRONICS; minneapolis MN 55432 560
• MDR Report Key: 4734117
• MDR Text Key: 5583177
• Report Number: MW5042331
• Device Sequence Number: 1
• Product Code: LRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2015

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 Model Number: MCEN118
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR