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

Model Number	E2781R-28ASP
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/08/2017
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 prior to the start of the procedure while preparing the device, the black shaft of the electrode started moving upon connecting with handle and the electrode eventually disconnected from the handle.A new electrode was opened to continue.There was no patient involvement.Medtronic's initial analysis found the black insulation on the tube and the mechanical assembly that controls the insulation position over active electrode had completely separated from the rest of the electrode.The insulation easily slid up the electrode.The insulation did not detach from the electrode however the bare metal of the electrode was exposed.The device failed hipot testing.
Additional Manufacturer Narrative
Visual inspection of the incident device found the black insulation on the electrode shaft and the mechanical assembly that controls the insulation position over the tip of the electrode to have completely separated from the rest of the electrode.The insulation easily slid up the electrode.The insulation did not detach from the electrode however the bare metal of the electrode was exposed.The device failed hipot testing.This is a supplier related failure.The supplier evaluated the device and identified the failure to be at the induction bond between the inner hub and the insulation material and to be the result of inadequate abrading of the bond area.Corrective action is being issued.No trend has been identified.Review of the manufacturing non-conformance records did not identify any pertinent entries.
Event or Problem Description
The customer reported that prior to the start of the procedure while preparing the device, the black shaft of the electrode started moving upon connecting with handle and the electrode eventually disconnected from the handle.A new electrode was opened to continue.There was no patient involvement.Medtronic's initial analysis found the black insulation on the tube and the mechanical assembly that controls the insulation position over active electrode had completely separated from the rest of the electrode.The insulation easily slid up the electrode.The insulation did not detach from the electrode however the bare metal of the electrode was exposed.The device failed hipot testing.

• 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: 6439531
• Report Number: 1717344-2017-05153
• Device Sequence Number: 16294520
• Product Code: GEI
• UDI-Device Identifier: 10884524000701
• UDI-Public: 10884524000701
• 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): 05/04/2017

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: 09/13/2021
• Device Model Number: E2781R-28ASP
• Device Catalogue Number: E2781R-28ASP
• Device Lot Number: 62170232X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• 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