MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GOLDVAC RS SMOKE PENCIL; GOLDVAC PENCILS

Catalog Number	60-7520-005
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to conmed for evaluation.The catalog and lot number were verified.Visual inspection found that the collet support hex was missing from the device.This is likely to be the piece that fell off the device.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformance's regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A review of this lot number, with (b)(4) pieces, showed no other complaint for this lot product and event description.A two-year review of complaint history revealed one other similar complaint for this product family and failure mode.During this same time frame, (b)(4) devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4) percent, if all complaints were confirmed.The instructions for use advises the user of the following.These devices should be inspected before each use.Visually examine the devices for obvious physical damage including: a) cracked, broken, or otherwise distorted plastic parts b) broken or significantly bent connector contacts c) damage including cuts, punctures, nicks, abrasions, unusual lumps or significant discolorations.Verify that the electrode is fully and securely seated in the pencil before use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The conmed sales representative reported on behalf of the user facility that during pre-op testing for an orthopedic procedure, a piece of the 60-7520-005 goldvac smoke pencil fell out.The procedure was completed with an alternate device with 5 minute delay.No patient contact or injury was reported.This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: GOLDVAC RS SMOKE PENCIL
• Common Device Name: GOLDVAC PENCILS
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua CP 11 36; MX CP 1136
• MDR Report Key: 7715732
• Report Number: 3007305485-2018-00169
• Device Sequence Number: 19149811
• Product Code: GEI
• UDI-Device Identifier: 00653405056341
• UDI-Public: (01)00653405056341(17)200125(10)201801255
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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: 01/25/2020
• Device Catalogue Number: 60-7520-005
• Device Lot Number: 201801255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1