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

Model Number	VL2610
Medical Device Problem Codes	Device Remains Activated (1525); Failure to Fire (2610)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the cut and coag keys were locked.No patient involvement.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medwatch number 1717344-2018-00212 is an invalid report.This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.This event has been reassessed.The event is no longer considered a malfunction mdr reportable complaint and is now classified as a malfunction non-mdr reportable complaint.New information has been received with the following information updated in event description: according to the reporter, prior to use, the device cut and coag keys couldn't be pressed and were locked, consequently as the buttons were locked it cant be activated.This issue was found right after opening the package.No patient involvement.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one vl2610 sample was received and a visual inspection and functional testing were performed by the supplier.This product had been used for treatment.Inspection of the sample noted that the blue and yellow buttons could not be pressed.Further investigation revealed that the root cause is related to the switch within the pencil being placed in an incorrect position during manufacture.Appropriate corrective action has been initiated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 7267327
• Report Number: 1717344-2018-00212
• Device Sequence Number: 1823958
• Product Code: GEI
• UDI-Device Identifier: 20884521196633
• UDI-Public: 20884521196633
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K982743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/04/2018

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 Expiration Date: 08/31/2022
• Device Model Number: VL2610
• Device Catalogue Number: VL2610
• Device Lot Number: 1708205X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 01/30/2018; 01/30/2018; 05/18/2018; 05/18/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/01/2018; 03/01/2018; 05/24/2018; 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1