Catalog Number 8065750597 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
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Event Description
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A customer reported "no tissue" burning effect when firing the laser.During a follow up, the customer reported that during the laser treatment it did not appear that the laser was working (no change to the tissue).They tested the laser with tissue paper and was not able to see any laser marks on the tissue paper.They cancelled the patient procedure.The procedure will be rescheduled once the system has been serviced.There was no patient harm.
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Manufacturer Narrative
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The company service representative examined the system but was unable to replicate the reported event.The system was then tested and met all product specifications.The system was manufactured on september 2, 2009.Based on qa assessment, the product met specifications at the time of release.A review of complaints for the last 24 months did not indicate any additional related reports for this system serial number.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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