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

Model Number 0703-001-000

Device Problems Circuit Failure (1089); Melted (1385)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

Stryker neptune was plugged in and being used on a surgical procedure.The machine turned off and began to smell as if it were burning.The unit was unplugged and replaced with a different unit.Stryker was called in to review/repair.They discovered a blown fuse and holder melting.They replaced these, along with the power entry module.Unit passed all testing and was put back into service.

• Brand Name: STRYKER NEPTUNE
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 16597847
• MDR Text Key: 311961665
• Report Number: MW5115923
• 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