MAUDE Adverse Event Report: GYRUS ACMI, INC. BUGBY WITH MONOPOLAR ACTIVE CORD; ELECTRODE, ELECTROSURGICAL, ACTIVE, CORD, UROLOGICAL

Model Number 257-6FR

Device Problems Break (1069); Detachment Of Device Component (1104); Fire (1245)

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

Event Date 09/29/2017

Event Type  malfunction  

Event Description

The bugby cord came apart where the active cable broke off from the cord.The cord still attached to the electrosurgical machine began to flame up for a few seconds before being put out with normal saline.

Event Description

The bugby cord came apart where the active cable broke off from the cord.The cord still attached to the electrosurgical machine began to flame up for a few seconds before being put out with normal saline.

• Brand Name: BUGBY WITH MONOPOLAR ACTIVE CORD
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, CORD, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike road; southborough MA 01772
• MDR Report Key: 6964877
• MDR Text Key: 89845636
• Report Number: 6964877
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 257-6FR
• Device Catalogue Number: 257-6FR
• Device Lot Number: 0344AA
• Other Device ID Number: ACTIVE CABLE C650-129A
• 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: 10/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BOVIE MACHINE
• Patient Age: 62 YR