Catalog Number 8065751762 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Key or Button Unresponsive/not Working (4063)
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Patient Problems
Corneal Edema (1791); Unspecified Eye / Vision Problem (4471)
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Event Date 09/20/2023 |
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 an ophthalmic foot pedal did not respond during surgery, the patient¿s eye was open for so long, a lot of corneal edema developed, which resulted in very limited vision.The procedure details was not reported.The current outcome of the patient was unknown.Additional information has been requested and non received till date.
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Manufacturer Narrative
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Additional information provided in sections h.6.And h.10.There was no service has been requested by the customer in response to the reported event.Therefore, an onsite assessment of the product was not performed.Based on the information available, the customer reported event cannot be confirmed.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 serial under investigation.The customer reported event cannot be confirmed.Based on the information obtained, 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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Manufacturer Narrative
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The footswitch was received for testing on this investigation.A visual assessment of the returned sample revealed no obvious nonconformity.The footswitch was installed into a calibrated system and turned on.Functional testing confirmed the reported event.The returned footswitch was defective because of a cold solder at j1 connector of the footswitch dome up-switch pcb.The root cause of the reported ¿system message code being displayed¿ is attributed to a cold solder at j1 connector of the footswitch dome up-switch pcb.The root cause of the reported ¿corneal edema/limited vision¿ cannot be conclusively determined, based upon the information provided to date.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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Manufacturer Narrative
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The fda product problem code has been updated from 2993 to 4063.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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