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

Model Number 0703047000

Patient Problems Laceration(s) (1946); Superficial (First Degree) Burn (2685)

Event Date 09/12/2023

Event Type  malfunction  

Event Description

This issue has happened 5 different times.Event #1: patient is an elderly female with diagnosis of pelvic mass who underwent a very extensive exploratory laparotomy with total hysterectomy and creation of ileostomy.This was a very long complex procedure that lasted approximately 5.5 hours during which at some point, unable to determine exactly when, the patient suffered a 1cm laceration as a result of the bovie.It was identified by the surgical technician that due to the bovie not having been placed back into the holster, it was inadvertently activated by means of either leaning over or another device set on top of it, hitting the button which activated the device, resulting in the injury.Event #2: patient is an elderly male who came in for an elective outpatient left inguinal hernia repair.Electrocautery pencil was intermittently in use during this procedure.The cautery pencil was laid onto the patient by the resident who was working on one side of the patient.Almost immediately after being laid down, the attending surgeon on the opposite side of the patient inadvertently leaned against the cautery pencil pressing the activation button which was audibly heard.A single holster was present in the surgical field.As a result of the activation, the patient had a 2cm laceration to his abdomen in the right lower quadrant which required 1 stitch to repair.The procedure continued without complication and the patient was discharged home post procedure as planned.During interviews with the involved providers, both shared they were unaware of any recent electrocautery events which were contained in the original education distribution.Event #3: upon removal of surgical drapes, the patient was found to have a burn on the right upper quadrant of the abdomen.The bovie was laying on the patient and was leaned up against.Bovie was not placed in the plastic holster.Event #4: patient in operating room (or) for: ultrasound guidance left common femoral artery, diagnostic aorto-iliac angiogram, right lower extremity diagnostic angiogram, placement 6 x 100mm self expanding covered stent, post stent angioplasty with 5 x 200mm balloon, completion right lower extremity angiogram, right groin exploration, evacuation hematoma, primary repair bovine pericardial patch, sartorius muscle flap mobilization, wound vac (vacuum assisted closure) placement right groin, central line insertion right subclavian.An inadvertent superficial bovie injury to skin occurred to left lower quadrant (llq); repaired with 4-0 monocryl suture and sterile dressing applied.Event #5: an elderly female was in the operating room for exploratory laparotomy, small bowel resection, primary side to side small bowel anastomosis, side to side ileo ascending colon anastomosis, peritoneal and mesenteric tumor debulking, and primary ventral hernia repair x 2.I think it must have been a hot bovie tip that touched her skin.It was superficial and small.It was in the context of control of bleeding and a difficult gi case with lots of commotion and clinically the least of her issues.Manufacturer response for stryker neptune smoke evacuation pencil, (brand not provided) (per site reporter).Stryker is taking the rocker switch ones from us and giving us the push button ones.

• Brand Name: NEPTUNE E-SEP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 17772799
• MDR Text Key: 323714427
• Report Number: 17772799
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0703047000
• Device Catalogue Number: 0703-047-000
• Device Lot Number: 214520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1