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 Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of initial report: (b)(6) 2016.To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The customer reported that the activation button keeps sticking on the handset.There was no injury to the patient.The issue was solved by using a new device.

• 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: 6178832
• Report Number: 1717344-2016-01170
• Device Sequence Number: 862598
• Product Code: GEI
• UDI-Device Identifier: 10884524000435
• UDI-Public: 10884524000435
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 12/05/2016

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1