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

Lot Number 56945646

Device Problem Defective Device (2588)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

The neptune smoke evacuation pencil was in the holder on the sterile field, no one was touching it.The pencil activated in cut mode.This occurred before the case started.The neptune was turned off, and the pencil was disconnected.There was no harm to anyone.A fault with the cable from the pencil was found and reproducible.The pencil lot number 56945646 was removed from stock and returned to stryker.A replacement pencil was used for the case and the system worked properly.

• Brand Name: NEPTUNE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage MI 49002
• MDR Report Key: 15224776
• MDR Text Key: 297893100
• Report Number: 15224776
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 56945646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3285 DA
• Patient Sex: Female