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

Model Number 0703-001-000

Device Problems Melted (1385); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2023

Event Type  malfunction  

Event Description

Stryker neptune was being used during a surgical procedure.Alarm went off and a burning smell was noted.The screen on the machine began to flicker.The staff looked at the cord and noted that it was melting and very hot at the outlet.They removed the equipment and replaced with another and no additional issues.Stryker was called to come in and repair.They discovered the power entry module was broken and that the power cord was melted and missing a prong.The power entry module and cord were replaced and the machine passed safety inspection.

• Brand Name: STRYKER NEPTUNE
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 16597924
• MDR Text Key: 311960960
• Report Number: MW5115924
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/20/2023

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: 0703-001-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1