A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The sample was received with inner blister, outer blister and with cover foil.The sample shows no macroscopic signs of damage.The sample was functionally tested with the outpatient laser console.Forceps was used as an essay.The surgical laser recognized the device.During the investigation, the sample was tested with the foot switch and also with different programs.The device was fully functional.The customer's complaint was not confirmed.The root cause cannot be identified conclusively because the sample met specifications.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.The manufacturer internal reference number is: (b)(4).
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