Device returned to manufacturer for evaluation on 07/26/2017.The block, which locks in the electrode and where the hf cable is connected, was loose and moving out of position.Due to the block moving the electrode may have been misaligned or not inserted completely and arching/sparking occurred.Charring on the proximal end of the electrode supports this conclusion.In addition, the shaft of device was bent and heavily dented due to rough handling.Per instruction manual, "immediately before and after each use, check the products for damage, loose parts and completeness.Do not use the products if they are damaged or incomplete or have loose parts." device is almost 6 years old and rwmic has no record of device being sent in for routine maintenance or repair since the purchase on (b)(6) 2013.Rwmic contacted initial reporter at the facility, via email, and requested medwatch missing information.No response as of 08/07/2017.Rwmic considers this matter closed, however, in the event additional information is received, rwmic will submit a follow-up report to the fda.
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Richard wolf medical instruments corporation (rwmic) was notified by a company representative that during a procedure a spark was seen.No illness / injury were report and there were no delays in the procedure which put the patient at risk.Back up device available for use and procedure was completed as scheduled.Initial reporter has been contacted, via email, in efforts to gather required medwatch information.Rwmic has not received a response as of 08/07/2017.Manufacture date: dec2012.Purchase date: (b)(6) 2013.Service dates: none on record.
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