Model Number TABLETOP |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problems
Retinal Detachment (2047); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/16/2023 |
Event Type
Injury
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Event Description
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A physician reported that during vitrectomy while using an ophthalmic console the laser was not effective.Surgery was concluded by replacing the laser with cryotherapy, thus changing the type of procedure.Patient harm was not reported.
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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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Manufacturer Narrative
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The company representative did not confirm nor replicate the reported event.The system was tested and found to meet product specifications.A non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A 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 serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The system was found to have no problem.Therefore, 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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Event Description
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Additional information required clarifying that the patient has returned to the emergency room with secondary retinal detachment, which will require reoperation.
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Search Alerts/Recalls
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