Catalog Number 8065751782 |
Device Problem
Material Separation (1562)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/02/2020 |
Event Type
malfunction
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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.(b)(4).
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Event Description
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A customer reported one of the trocars, at the time of removal during a procedure, the metal part was missing.A search for the metal part in the surrounding operative area and in the surgical area (inside the eye) was carried out with negative results.
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Event Description
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Additional information was received from the customer.The customer indicated they will provide additional information when it becomes available and the product sample is not available.
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Manufacturer Narrative
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Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The previous report submitted for this event contained an error in h.1.¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Manufacturer report number 2523835-2020-0277 was submitted in error.The original report was submitted under manufacturer report number 2523835-2020-0277.Please refer to manufacturer report number 2028159-2021-00224.No further reports will be submitted under manufacturer report number 2523835-2020-0277.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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