MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E3305
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The customer reported that the button on the device which allows you to suction or coagulate stays in coagulate mode.The issue resulted in unintended burning of tissue.
Additional Manufacturer Narrative
Evaluation summary: one e3305 was received and evaluation of the returned device confirmed the reported condition that the device was latched on/self-keying.Visual inspection found no defects.The device was plugged into a 40k-ohm test box with unsatisfactory results.It immediately began activating without touching the activation button.The product engineering evaluating the product disassembled the device and determined there were no defects with the any of the device's components.The investigation was not able to identify any issues related to manufacturing or the supplier that might have contributed to the observed condition.The investigation could not determine the root cause of the reported condition.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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 MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 6950012
• Report Number: 3006451981-2017-05676
• Device Sequence Number: 10933606
• Product Code: GEI
• UDI-Device Identifier: 10884524002026
• UDI-Public: 10884524002026
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091223
• 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,Followup
• Report Date (Section B): 01/31/2018

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: 09/01/2019
• Device Model Number: E3305
• Device Catalogue Number: E3305
• Device Lot Number: S4JE009X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 11/28/2017; 01/07/2018
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 12/18/2017; 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1