MAUDE Adverse Event Report: CONMED; CONMED CAUTERY DEVICE IN SHELBY OPEN HEART SUPPLY

Catalog Number	DYNJ57505A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an unidentified procedure, the cautery device caught on fire.After multiple good-faith attempts, the facility remained unable or unwilling to provide additional patient, product, or procedural information related to this incident.No serious injury, medical intervention, or follow-up care was originally reported.No impact to a patient, a patient's stability, or to the unidentified procedure was originally reported.No impact to a staff member was originally reported.No sample was returned to the manufacturer for evaluation.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during an unidentified procedure, the cautery device caught on fire.

• Common Device Name: CONMED CAUTERY DEVICE IN SHELBY OPEN HEART SUPPLY
• Manufacturer (Section D): CONMED; 525 french road; utica NY 13502 5945
• MDR Report Key: 7676996
• Report Number: 1423395-2018-00036
• Device Sequence Number: 789578
• Product Code: OJH
• UDI-Device Identifier: 10889942850372
• UDI-Public: 10889942850372
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ57505A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other