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

Model Number NEPTUNE 3 ROVER

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

The neptune 3 rover waste management system by stryker had a strong foul electrical smell in the or during a cv case.The power circuit board had a partially melted fuse holder.The unit did not lose power, there was no smoke, and the fuse did not blow.The unit was turned off and removed from the room.The repair included replacing the ¿pc board¿ and the ¿acpd¿.These parts were returned to stryker engineering for diagnostics.Since this event we have had one more failure of these same components in a different rover.There was no patient harm in either case.

• Brand Name: NEPTUNE
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage MI 49002
• MDR Report Key: 17376030
• MDR Text Key: 319577393
• Report Number: 17376030
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/22/2023

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: NEPTUNE 3 ROVER
• Device Catalogue Number: 0703001000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2023
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1825 DA
• Patient Sex: Male