MAUDE Adverse Event Report: COVIDIEN (MEDTRONIC); COVIDIEN CAUTERY DEVICE IN PK, GEN-MINOR-MH

Catalog Number DYNJ62508

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the during a deep intramuscular resection the covidien cautery device tip was identified to be sparking.When this was identified, the cautery device tip was removed and replaced with a new cautery device tip.No further procedure-relate incident was reported to the pack manufacturer.According to the reporting facility, there was no patient injury related to the incident.Covidien, the cautery device manufacturer, was notified of the incident by the pack manufacturer.Due to the reported incident of sparking, 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 covidien cautery device tip was sparking during a procedure.

• Type of Device: COVIDIEN CAUTERY DEVICE IN PK, GEN-MINOR-MH
• 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: 9268263
• MDR Text Key: 190758736
• Report Number: 1423395-2019-00045
• Device Sequence Number: 1
• Product Code: LRO
• 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 faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ62508
• Device Lot Number: 19EBQ561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 111