Catalog Number 8065750833 |
Device Problems
Energy Output Problem (1431); Failure to Read Input Signal (1581); Application Program Problem (2880)
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Patient Problem
Burn, Thermal (2530)
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Event Date 10/08/2020 |
Event Type
Injury
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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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that during a cataract procedure, a patient experienced a small burn in the main incision.Two sutures were required to close the wound.A contact lens was also placed on the eye.The customer believes there is a potential mismatch between the programmed ultrasound power delivered causing the event.
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Manufacturer Narrative
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Additional information provided in h.6.And h.10.A review of the service records (sr) showed that there was no sr open for this event.It should be noted that on (b)(6) 2020, an sr was opened for preventative maintenance (pm) was performed.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported events could not be confirmed.The root cause of the reported events cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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