MAUDE Adverse Event Report: AESCULAP MONOPOLAR CORD CABLE; CORD, ELECTRIC, FOR ENDOSCOPE

Model Number GK246

Device Problems Break (1069); Material Separation (1562); Sparking (2595)

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

Event Date 11/17/2016

Event Type  malfunction  

Event Description

The surgeon was using a bugbee monopolar instrument that was attached to the bovie machine with a cable.During use, the tip of the cord that was attached to the bovie machine sparked and the cord broke into 2 pieces.A second cord was opened and the vessel was sealed off without problems.

• Brand Name: MONOPOLAR CORD CABLE
• Type of Device: CORD, ELECTRIC, FOR ENDOSCOPE
• Manufacturer (Section D): AESCULAP; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 6213530
• MDR Text Key: 63557159
• Report Number: 6213530
• Device Sequence Number: 1
• Product Code: FFZ
• 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
• Report Date: 12/05/2016

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: GK246
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 72 YR
• Patient Weight: 63