Catalog Number 8065797303 |
Device Problem
Gas Output Problem (1266)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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No sample has been received by manufacturing for evaluation.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.(b)(4).
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Event Description
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A materials manager reported that an ophthalmic gas dispensing regulator valve would intermittently indicate the available gas pressure, but was unable to dispense gas prior to the start of vitrectomy surgery.There was no patient harm associated with this event that was noted prior to surgery.
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Manufacturer Narrative
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A sample is available that has not yet been received by manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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A review of the manufacturing records did not reveal any related nonconformity during manufacturing for this product.Based on qa assessment, the product met specifications at the time of release.An ophthalmic gas dispensing regulator sample was received and testing was performed on the returned sample.The creep test performance was below specification.Additionally, testing of the regulator flow at 320 psi headspace pressure was performed which was found to meet specifications.While the complaint was confirmed, it is however unknown whether the nonconformities found would have contributed to the customer¿s observations.The root cause cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending with further action taken, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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