MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number BD 1/17

Device Problems Thermal Decomposition of Device (1071); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2022

Event Type  malfunction  

Event Description

Surgeon requested that the bovie be turned to 40/40 while using the l-hook; at this time, we noticed that the monopolar cord was burning at the attachment to the bovie, and had completely separated from the remainder of the cord on the field.

• Brand Name: BD CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BECTON, DICKINSON & CO.; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 14631171
• MDR Text Key: 293538663
• Report Number: 14631171
• 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: 05/18/2022

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: Health Professional
• Device Model Number: BD 1/17
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: Black Or African American