Model Number TABLETOP-JAPAN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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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 physician was reported that an ophthalmic operating console caused bleeding spots in dot-shape in the retina of a patient post operatively.The scheduled procedure was vitrectomy.The condition of patient will be under observation.Additional information has been requested but none received till date.
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Manufacturer Narrative
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No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per a service record (sr).The system found to meet all cosmetic and performance standards per the service test procedure (stp).A system manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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