MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN CABLE OR ACCESSORIES; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number UNKNOWN CABLE OR ACCESSORIES

Device Problems Fire (1245); Arcing (2583); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

Uf/importer report#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device cord wouldn't work on first bovie machine, got another bovie to see if it was the machine or the cord not working.The instrument started to work with the second bovie then all of a sudden, heard a pop and saw that the bovie cord sparked and severed the cord, with both ends having a flame.Removed bovie from source and dropped cord to floor so it wouldn't burn the drapes causing an actual fire.Both bovies work with new cords.

• Brand Name: UNKNOWN CABLE OR ACCESSORIES
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15987580
• MDR Text Key: 305520892
• Report Number: 1717344-2022-01542
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN CABLE OR ACCESSORIES
• Device Catalogue Number: UNKNOWN CABLE OR ACCESSORIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female