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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of initial report: (b)(6) 2016.The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.
Event or Problem Description
The customer reported that the device would not disengage and was stuck in the on position.After changing out the handpiece the issue was corrected.There was no injury to the patient.
Additional Manufacturer Narrative
(b)(4).Evaluation of the incident pencil found the tactile feel of the rocker switch was abnormal in that it did not snap back to the off position.Testing found the pencil to immediately begin self-keying in the coagulation mode.The self-activation could be stopped and restarted by manipulating the rocker switch.Two possible causes were identified.The gate vestige on the rocker could have created interference between the rocker and the handle body opening, creating the reported condition.Secondly, a tolerance stack up between the handle bodies and the rocker width specification.A tight fit between the handle body and the rocker could result in the condition described if the device is held with a heavy grip.Review of the manufacturing non-conformance records found the lot was released meeting specifications.No trend has been identified for this failure mode.
Additional Manufacturer Narrative
(b)(4).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: 5755035
• Report Number: 1717344-2016-00571
• Device Sequence Number: 315107
• Product Code: GEI
• UDI-Device Identifier: 10884524000435
• UDI-Public: 0110884524000435
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K964175
• 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): 06/01/2016

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: 04/01/2021
• Device Model Number: E2750
• Device Catalogue Number: E2750
• Device Lot Number: 60520104X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/01/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/28/2016
• Supplement Report FDA Received Date: 07/14/2016; 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1