MAUDE Adverse Event Report: COVIDIEN LP E2781R-28ASP OPTI4 CURVED SPAT; LAP ELECTRODE, CURVED SPATULA TIP

Model Number	E2781RS
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2016
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 originally reported that during a proctectomy, the tip of the device melted and sparked.Another device was then used to complete the procedure with no patient injury.The device was returned for evaluation and the area around where the electrode melted failed hipot testing.
Additional Manufacturer Narrative
(b)(4).Date of initial report: 09/06/2016.Date of follow-up report: 10/05/2016.Evaluation of the incident device found blood inside the tube and on the spatula tip.The insulation was melted at the aspiration holes.The device failed hipot testing at the location of the melted insulation.The excessive blood inside the aspirator tube created a conductive path between the active electrode and the external surface of the electrode insulation.The instructions for use warns irrigation fluid must be cleared and suction activated prior to activation the electrosurgical handset to prevent this type of occurrence.This product is hipot tested prior to release.Review of the manufacturing non-conformance records found the product was released meeting specifications.

• Brand Name: E2781R-28ASP OPTI4 CURVED SPAT
• Common Device Name: LAP ELECTRODE, CURVED SPATULA TIP
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 5928705
• Report Number: 1717344-2016-00831
• Device Sequence Number: 16363486
• Product Code: GEI
• UDI-Device Identifier: 10884524000701
• UDI-Public: 0110884524000701
• 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
• Report Date (Section B): 09/02/2016

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 Model Number: E2781RS
• Device Catalogue Number: E2781RS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2016
• Supplement Report FDA Received Date: 10/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1