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

Model Number 0703-047-000

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2021

Event Type  malfunction  

Event Description

Upon inserting the smoke evacuator bovie into the neptune, the plastic cord cracked.Rn was able to secure it to work for the case.Product has been removed from service, product failure has been filled out and company rep will look into the lot number.

• 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: 11588308
• MDR Text Key: 242932376
• Report Number: 11588308
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0703-047-000
• Device Lot Number: 2037041
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 29