MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E2781R-28ASP
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during the procedure, mist was emitted from the black part of the shaft and from the aspiration hole.The insulation at the proximal seemed burnt.The shaft was melted and no metallic material was around the spatula.A new device was used to continue the procedure.There was no patient harm.Medtronic's initial evaluation found the device failed hipot testing around the melted insulation.
Additional Manufacturer Narrative
The investigation found a section of the insulation around the irrigation holes to have melted.The melting occurred as a result of arcing.Two possible sources of arcing were identified.Simultaneous activation of the suction function and the electrical current could result in increased arcing at either the electrode tip or aspiration holes, causing the insulation to melt.Or activating the electrode while retracted in the sheath could result in arcing through the aspiration holes and potential melting.The instructions for use state, simultaneously activating suction/irrigation and electrosurgical current may result in increased arcing at either the electrode tip or aspiration holes, and/or burns to adjacent tissue.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during the procedure, mist was emitted from the black part of the shaft and from the aspiration hole.The insulation at the proximal seemed burnt.The shaft was melted and no metallic material was around the spatula.A new device was used to continue the procedure.There was no patient harm.Covidien's initial evaluation found the device failed hipot testing around the melted insulation.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 6523449
• Report Number: 1717344-2017-05254
• Device Sequence Number: 16276336
• Product Code: GEI
• UDI-Device Identifier: 20884524000708
• UDI-Public: 20884524000708
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944244
• 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): 05/07/2017

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: 10/13/2021
• Device Model Number: E2781R-28ASP
• Device Catalogue Number: E2781R-28ASP
• Device Lot Number: 62410137X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 05/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1