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

Model Number 0703001000

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Device Emits Odor (1425); Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2021

Event Type  malfunction  

Event Description

While operating we smelled a burning smell, we checked the patient and he was fine, so we called the charge nurses to come help us search the room to locate the source.While searching, we found the smell to be heavy in the area around the surgical field and noticed that the suction was powered off and had been on throughout the case.We called biomed and he came to the room and removed the suction from the operating room.Upon inspection biomed found the circuit board to be melted and burnt.Manufacturer response for waste management system, (brand not provided) (per site reporter).Troubleshooting-- i was called to operating room 7 for a strong burning smell and what they said was smoke.When i got in the room we were able to unplug the equipment.The doctor then stated he needed suction.We plugged the neptune back in and the power would not come back on.We found the smell to be coming from the neptune.I took the device back to my shop where i was able to disassemble the neptune.I found that the power board had fuse on it that was burned/melted.This is a common issue with the neptunes.I contacted stryker rep to inform him of the issue.I was also told by the rep that stryker engineers are aware of the issue and working on a fix.Contacted vendor-- spoke with vendor.They will be in tomorrow to replace the board.Repaired by vendor.

• Brand Name: NEPTUNE
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 11862822
• MDR Text Key: 251944005
• Report Number: 11862822
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2021

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: 0703001000
• Device Catalogue Number: 0703001000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1