MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VLFT10GENZD
Medical Device Problem Codes	Energy Output Problem (1431); Self-Activation or Keying (1557); Device Displays Incorrect Message (2591); Connection Problem (2900); Intermittent Energy Output (4025)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation.From the provided information, it is unknown if the device has or has not been used in the treatment or diagnosis of a patient.The returned sample did not meet specification as received by medtronic.A visual inspection of the generators exterior found the rear ethernet cover missing.The reported condition was confirmed.The investigation isolated the failure to the steering relay board.The steering relay board was replaced to address the condition.Corrective actions have been implemented to mitigate this issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the monopolar cut mode was activated when coagulate button was pressed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the monopolar 1 cut is activated when coag button is pressed.There is also a intermittent power when the pencil activated while plugged into monopolar 1 and had a e213 error code.Another generator was used to complete the procedure.No patient injury.No further information available at this time.

• Brand Name: VALLEYLAB FT10
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7754011
• Report Number: 1717344-2018-01039
• Device Sequence Number: 186494
• Product Code: GEI
• UDI-Device Identifier: 10884521640474
• UDI-Public: 10884521640474
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K001955
• 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,Followup,Followup
• Report Date (Section B): 10/04/2018

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 Model Number: VLFT10GENZD
• Device Catalogue Number: VLFT10GENZD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 08/08/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/29/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1