MAUDE Adverse Event Report: CONMED CORPORATION GOLDVAC PUSH BUTTON SMOKE EVACUATION PENCIL, 10' TUBING

Model Number	N/A
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to conmed corporation on 17-nov-2016 was examined in the laboratory and confirmed as catalog number 60-7510-005 goldvac¿ push button smoke evacuation pencil, 10' tubing.The examination of the device found no visible defects or damage associated with the device.The handpiece was functionally tested using the system 7500 esu.The monopolar plug was inserted into the receptacle and the power was turned on.After the post testing was complete, an err 2 was displayed and the coag tone sounded [err 2 - footswitch or handpiece shorted.Replace defective accessory].The complaint of "cautery pencil turned on without cut or coag button being depressed" was confirmed.Following the confirmation of the complaint issue, the device was disassembled and reexamined.It was observed that the wire from the common terminal (green wire) was found to be in contact with the coag terminal (red wire) resulting in a short in the coag circuit.The device was manufactured on 13-jun-2016.A review of the manufacturing documents from the dhr/lhr has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.Of the lot containing (b)(4) units, there was no other similar complaint received for this item and lot number combination.A 2 year review of product history for this device family showed there have been a total of (b)(4) similar occurrences of self-activation, including this complaint.(b)(4).Similar events have been previously identified and address in a capa root cause investigation.This capa was closed 18-oct-2016.This complaint device was manufactured prior to the closure of this capa root cause investigation; no further root cause investigation is required at this time; however, the reported complaint issue will continue to be monitored through the complaint system.To reduce the risk of patient/user injury the instruction for use (ifu) of the goldvac pencil provides the following precautions and warnings: always place unused associated electrosurgical accessories in a safe insulated location such as in the provided holster when not in use.
Event or Problem Description
As reported by the user facility, "on (b)(6) 2016, a goldvac pencil, ref 60-7510-005, activated prior to use on patient without depressing the push button to activate the pencil." there was no harm to the operating room staff and there was no patient involvement.The patient was able to have the right vats lung biopsy procedure using another like device that was on hand with only a 5 minute delay.This report is filed on the basis of potential injury with recurrence.

• Brand Name: GOLDVAC PUSH BUTTON SMOKE EVACUATION PENCIL, 10' TUBING
• Common Device Name: SMOKE EVACUATION PENCIL
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6114613
• Report Number: 3007305485-2016-00142
• Device Sequence Number: 19124758
• Product Code: GEI
• UDI-Device Identifier: 00653405056334
• UDI-Public: (01)00653405056334(17)180613(10)201606135
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

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: 06/13/2018
• Device Model Number: N/A
• Device Catalogue Number: 60-7510-005
• Device Lot Number: 201606135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1