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

Catalog Number DYNJ0977627F

Device Problem Fire (1245)

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

Event Date 09/01/2019

Event Type  malfunction  

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 Description

It was reported that the tip of the covidien cautery device caught on fire.

• Type of Device: COVIDIEN CAUTERY DEVICE IN LAPAROTOMY UNIVERSAL PACK-LF
• Manufacturer (Section D): COVIDIEN (MEDTRONIC); 710 medtronic parkway; minneapolis MN 55432 5604
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9130567
• MDR Text Key: 166227451
• Report Number: 1423395-2019-00033
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942551545
• UDI-Public: 10889942551545
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other