MAUDE Adverse Event Report: COVIDIEN (MEDTRONIC); COVIDIEN CAUTERY DEVICE IN LAPAROTOMY UNIVERSAL PACK-LF

Catalog Number	DYNJ0977627F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the tip of the covidien cautery device caught on fire during an unidentified procedure.The settings and use of the covidien cautery device at the time of the incident are unknown.The settings and the type of generator used at the time of the incident are unknown.No impact or adverse effect to the patient, to the procedure, or to a staff member was reported to the procedure pack manufacturer.A sample cautery device and extender tip was returned to the pack manufacturer.Upon inspection of the component there was no noted damage on the sample received other than a slightly charred tip extender.A root cause for the reported incident could not be determined by the procedure pack manufacturer.Covidien was notified of the reported incident by the procedure pack manufacturer.Due to the reported fire, 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 the tip of the covidien cautery device caught on fire.

• Common Device Name: COVIDIEN CAUTERY DEVICE IN LAPAROTOMY UNIVERSAL PACK-LF
• Manufacturer (Section D): COVIDIEN (MEDTRONIC); 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 9130567
• Report Number: 1423395-2019-00033
• Device Sequence Number: 468584
• Product Code: LRO
• UDI-Device Identifier: 10889942551545
• UDI-Public: 10889942551545
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ0977627F
• Device Lot Number: 19FBG706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 09/27/2019
• 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