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	08/29/2016
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 prior to the start of the procedure, the coag button did not return once being pressed.There was no patient involvement.A new device was opened to continue.
Additional Manufacturer Narrative
Covidien reference#: (b)(4).Date of initial report: 09/29/2016.Date of follow-up report: 10/14/2016.Evaluation of the incident pencil confirmed the customer's report.The cause is due to an assembly related failure.
Additional Manufacturer Narrative
(b)(4).Date of initial report: 09/29/2016.Date of follow-up report: 10/14/2016.Date of follow-up report: 02/13/2017.Corrected information in evaluation codes.The customer reported the device had a latch-on condition.The reported condition was not confirmed.An additional fault was found during the investigation.The additional finding did not contribute to the customer¿s complaint.The investigation found the rocker switch activation force to be out of specification.The width of the rocker was found to be larger than the width of the rocker window in which it moves causing friction and an out of specification activation force.The width of the rocker window is formed by the ultrasonic welding of the two body housing components.The root cause of the activation force being out of specification was caused by interference between the rocker component and the rocker window in which it moves.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: 5987164
• Report Number: 1717344-2016-00907
• Device Sequence Number: 13571590
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2016

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: 09/06/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/29/2016
• Supplement Report FDA Received Date: 10/14/2016; 02/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1