MAUDE Adverse Event Report: GYRUS ACMI, INC MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS

Model Number C650-129A

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned to service center for the physical evaluation.The exact cause of the reported event cannot be determined at this time.The instruction manual for use states; examine this device prior to use.Do not use if damage is found.Do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.This product has a restricted service life.Do not use the cable for a period of more than one year.Using the cable beyond one year may be hazardous.Do not pull on the cord when unplugging it.Only pull on the plug.Pulling on the cord could cause damage that may be hazardous.

Event Description

The service center was informed that during an unspecified procedure, the bugbee cord caught fire.It was reported that the wire melted off and there was no other part of the wire that was on fire.The intended procedure was completed using a same device.No user or patient injury reported.Also, the lot/serial number is unknown for this device.No report of emergency fire evacuation reported.

• Brand Name: MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
• Type of Device: MONOPOLAR ACTIVE CORD
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8708469
• MDR Text Key: 148318660
• Report Number: 2951238-2019-00955
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C650-129A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: COVIDIEN CAUTERY UNIT