MAUDE Adverse Event Report: STRYKER INSTRUMENTS NEPTUNE E-SEP; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 0703047000

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2022

Event Type  malfunction  

Event Description

Stryker neptune e-sep smoke evacuation pencil coated, 70mm blade, rocker switch, ref 0703-047-000, lot 59053479.Unit connected to esu not functioning, switched connections with no change.New unit opened and functioned.

• Brand Name: NEPTUNE E-SEP
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 15931538
• MDR Text Key: 304969736
• Report Number: 15931538
• Device Sequence Number: 1
• Product Code: GEI
• 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: 11/28/2022

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 Model Number: 0703047000
• Device Catalogue Number: 0703-047-000
• Device Lot Number: 59053479
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Male
• Patient Race: White