MAUDE Adverse Event Report: CONMED ELECTROSURGERY GOLDVAC PUSH BUTTON ELECTROSURGICAL PENCIL WITH 15 FOOT CORD; GOLDVAC PENCIL

Catalog Number	60-7570-005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) goldvac push button electrosurgical pencil with 15 foot cord was returned to the conmed for evaluation regarding a complaint of "the cautery activated by itself, in holster".The device was examined and functionally tested in the laboratory; a visual inspection noted no damage or visible defects associated with the returned device.A functional test was performed using the returned goldvac pencil, a standard disposable holster supplied with the device and a system 7500 esu.The pencil was plugged into the esu and placed in the holster.After the esu was turned on, if the pencil is turned in the holster, the cut model on the esu will activated.In some instances, when the pencil is turned, it can be pinched in the holster resulting in the cut button being depressed, which in turns activated the cut mode of the esu.It is believed that the weight of the smoke evacuation tubing will pull on the pencil causing it to turn in the holster.This lot was manufactured 08-oct-2015.A review of the device history record for this lot found no non-conformances or abnormalities during the manufacturing process that could have caused or contributed to the reported issue.Of the lot containing a total of (b)(4), there have been no similar complaints received on this item and lot number combination.A two (2) year review of complaint history for this device family revealed a total of twenty-six (26) complaints for self-activation, including this complaint.During this same two (2) year time frame, (b)(4).Based on the preliminary investigation findings, an investigation has been initiated to determine the root cause and to address this issue.To reduce the risk of patient and end-user injury the ifu, instructions for use, provides the following precautions and warnings: - these devices should never be used in the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases such as nitrous oxide (n2o), or in oxygen-enriched environments.- always place unused associated electrosurgical accessories in a safe, insulated location such as the provided holster when not in use.
Event or Problem Description
During use of a goldvac push button electrosurgical pencil with 15 foot cord in a subtotal abdominal hysterectomy, the goldvac pencil was reported to self-activate in the safety holster at least twelve (12) times.It was reported that by just brushing against the side of the safety holster activated the pencil.The end-user states that they believe the activations are from the pencil being pinched in the safety holster.There is minimal risk for injury with the pencil activating within the safety holster.As reported, there was no user or patient injury reported with this reported problem.This report is being submitted due to potential for user/patient injury.

• Brand Name: GOLDVAC PUSH BUTTON ELECTROSURGICAL PENCIL WITH 15 FOOT CORD
• Common Device Name: GOLDVAC PENCIL
• Manufacturer (Section D): CONMED ELECTROSURGERY; 14603 east fremont avenue; centennial CO 80112
• MDR Report Key: 5524223
• Report Number: 3007305485-2016-00016
• Device Sequence Number: 16259223
• Product Code: GEI
• UDI-Device Identifier: 00653405061192
• UDI-Public: (01)00653405061192(17)171007(30)1(10)201510085
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/29/2016

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: 01/07/2017
• Device Catalogue Number: 60-7570-005
• Device Lot Number: 201510085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2016
• Initial Report FDA Received Date: 03/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other