MAUDE Adverse Event Report: COVIDIEN FILAC

Model Number	504000
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The unit was sent to a service center for repair.Upon triage, a technician found the pcb to have thermal damage on the right bottom area.The pins were burnt and a cavity was seen, filled with black residue.Black residue was also observed on the components surrounding the pins and fuse.It was unclear if these components suffered thermal damage.

• Brand Name: FILAC
• Manufacturer (Section D): COVIDIEN; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 6798564
• Report Number: 3006451981-2017-05509
• Device Sequence Number: 11155713
• Product Code: FLL
• UDI-Device Identifier: 20884521008455
• UDI-Public: 20884521008455
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

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: Other
• Device Expiration Date: 05/07/2023
• Device Model Number: 504000
• Device Catalogue Number: 504000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/16/2017
• Patient Sequence Number: 1