Model Number TABLETOP-JAPAN |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Hematoma (1884); Hemorrhage/Bleeding (1888)
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Event Date 01/30/2019 |
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 surgeon reported that he was performing a combination cataract/vitrectomy procedure.The cataract procedure was performed by a non-company system and then the vitrectomy was to be performed using our system.Three ports were made however the light guide did not work.The surgeon attempted to perform vitreous surgery under microscope as possible as he can, however, the surgeon was not able to have proper operative field so that he decided it was difficult to remove safely submacular hematoma.Vitreous humour and bleeding in vitreous humour were removed and aspirated as much as possible and the surgery was not completed as scheduled.Re-operation was performed the following day.
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Manufacturer Narrative
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The company service representative (ar) examined the system and replicated the reported event.The xenon lamp and the electrode tube were replaced to resolve the issue.The system was then tested and met all product specifications.The xenon lamp and the electrode tube were received and both samples did not show any obvious visual non-conformities.The lamp was installed in a calibrated vision system and tested.The sm [the lamp in the table top illuminator needs to be replaced.Please contact field service] displayed and an arcing sound was heard when the lamp was turned on.The reported event was replicated.The lamp was taken out of the system and inspected.One of the banana plugs was found to have a crimped connector resulting in an intermittent contact with the module electrodes.The tube electrodes were found to have no problem.The reported issue was caused due to the lamp having an intermittent ignition issue.The system was manufactured on june 6, 2013.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a non-conforming lamp.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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