MAUDE Adverse Event Report: STRYKER NEPTUNE 2 TOWER; APPARATUS, EXHAUST, SURGICAL

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Approximately mid case, when the surgeon switched to the right breast, the handpiece shaft was difficult to retract.The shaft had to be forced down, even after twisting the lock.There was not much tissue visible.Then the device was weak on cut and coag.Increasing the settings from 5/5 to 6/6 and then 7 /7 resolved the weak issue.The smoke evac then became weak.Staff changed ports on the stryker neptune 2 tower and flushed the hand piece tube with saline without resolution.Staff used hand held suction to complete the case.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEPTUNE 2 TOWER
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17527196
• MDR Text Key: 321170906
• Report Number: MW5134130
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1