MAUDE Adverse Event Report: GYRUS ACMI INC. GYRUS PK BUTTON FRONT LOADING ELECTRODE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number 786500

Device Problems Smoking (1585); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 11/23/2015

Event Type  malfunction  

Event Description

Surgeon completed using the device and noticed that it was smoking.After removal from the field and disassembly there was black soot noticed on the cable and disposable device.

• Brand Name: GYRUS PK BUTTON FRONT LOADING ELECTRODE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI INC.; 135 turnpike road; southborough MA 01772
• MDR Report Key: 5292440
• MDR Text Key: 33365314
• Report Number: 5292440
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: 786500
• Device Lot Number: U1508019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR