MAUDE Adverse Event Report: COVIDIEN LP LCD HANDSWITCH STERIL CS/10; ES ACCESSORY

Model Number	E2750
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of initial report: 09/22/2016.Evaluation of the incident pencil confirmed the customer's report.The cause is due to an assembly related failure.
Event or Problem Description
The customer reported that prior to use on a patient, the coag button was stiff and the device did not activate by pressing the button.There was no patient involvement.A new device was used to continue.Initial evaluation by medtronic found the pencil to intermittently latch on in the coag mode when the rocker switch was pressed.
Additional Manufacturer Narrative
(b)(4).The reported condition that the device did not activate was not confirmed.An additional failure of a latch-on condition was found during the investigation.Per engineering investigation, the ¿latch on¿ condition was caused by interference between the rocker component and the rocker window in which it moves.The width of the rocker was found to be larger than the width of the rocker window.The width of the rocker window is formed by the ultrasonic welding of the two body housing components.Corrective action is being issued.

• Brand Name: LCD HANDSWITCH STERIL CS/10
• Common Device Name: ES ACCESSORY
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 5971196
• Report Number: 1717344-2016-00870
• Device Sequence Number: 912669
• Product Code: GEI
• UDI-Device Identifier: 10884524000435
• UDI-Public: 0110884524000435
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2016

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: 03/10/2021
• Device Model Number: E2750
• Device Catalogue Number: E2750
• Device Lot Number: 60520098X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2016
• Supplement Report FDA Received Date: 01/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1