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

Model Number 0703046000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/08/2023

Event Type  malfunction  

Event Description

The patient is an elderly female that presented to orthopedics with severe arthritis of both hips, with the left being more significant than the right.On [redacted date], the patient was taken to the or for a left total hip replacement.During the middle of the procedure, the bovie was placed on top of the patient's left thigh on the exposed side covered by ioban.One of the surgical assistants accidentally laid his hand on the bovie causing a 3 x 3mm burn.At the end of the case, the surgical assistant requested for a dressing and when the circulator asked what it was for, it was disclosed that the patient sustained an accidental thermal burn.The burn was covered with an allevyn dressing and the injury was disclosed to the patient.1.Device does not have a mechanism to alert the user to return the device to the holster when not in use.2.Device does not have a mechanism to decrease the heat generated after use - making it return the heat after use causing potential burns when not in use.Manufacturer response for neptune safeair smoke evacuation pencil, neptune safeair smoke evacuation pencil (per site reporter).1.Will ask engineer if there are any differences beteen the ocker and push button switch.2.Will review education module given out to surgeons and staff.

• Brand Name: NEPTUNE E-SEP
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage MI 49002
• MDR Report Key: 17180995
• MDR Text Key: 317690273
• Report Number: 17180995
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0703046000
• Device Catalogue Number: 0703-046-000
• Device Lot Number: 2209001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female
• Patient Race: White