MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER NEPTUNE SMOKE EVACUATING PENCIL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0703-047-000

Device Problems Fire (1245); Improper or Incorrect Procedure or Method (2017); Arcing (2583)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 02/22/2023

Event Type  Injury  

Event Description

During a laparoscopic cholecystectomy, the surgeon used a stryker neptune smoke evaluation pencil (bovie) and set the pencil down on the operative field (holster was not used) and a raytec gauze caught on fire.Surgeon said the bovie arced and the raytec caught on fire.The surgeon threw the raytec on the floor and the fire went out.The surgical drape was singed and the patient suffered a small burn which was one inch by one fourth of an inch on her abdomen.The bovie was thrown out and a new bovie was used to continue the surgery.In addition to this case, we've had two reported instances of a stryker bovie activating unintentionally.Another one of our facilities has reported that the stryker pencil rocker switch is very sensitive and activated unintentionally if something brushes up against it.On (b)(6) 2023, we had an operating room fire while the stryker bovie was being used.The fire involved burns to the patient on his face, chest and back.We had other issues with this event related to the skin prep and oxygen under the drape and did not initially suspect the bovie but now we are wondering if the stryker bovie contributed to this event.Reference report: mw5115981, mw5115982.

• Brand Name: STRYKER NEPTUNE SMOKE EVACUATING PENCIL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS; kalamazoo MI 49001
• MDR Report Key: 16618435
• MDR Text Key: 312042033
• Report Number: MW5115980
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0703-047-000
• Device Lot Number: 62012084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White