MAUDE Adverse Event Report: COVIDIEN FILAC

Model Number 504000

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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
• Manufacturer (Section G): COVIDIEN; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6798564
• MDR Text Key: 83009526
• Report Number: 3006451981-2017-05509
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 20884521008455
• UDI-Public: 20884521008455
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/19/2017
• Date Device Manufactured: 05/17/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1