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Model Number 10562-1 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2023 |
Event Type
Injury
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Event Description
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Iridex became aware of a complaint reporting presence of smoke during treatment with an endoprobe.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Engineering failure analysis could not be performed because the device was not returned for evaluation.No additional information is available at this moment.Iridex will continue to follow-up with the doctor for information regarding patient recovery.
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Event Description
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Part a is not filled out as patient identifier details were not provided to iridex.This report has been created to make corrections to the previous report.The changes include: 1) report c: is this a combination product - no.3) part h: update to include that this a correction report.4) part d: updated this section with the udi number.5) part e: updates to the initial reporter section with information regarding the complainant.6) part h4: updates to date of manufacture.This information was not submitted previously.The following text were provided in the initial report: iridex became aware of a complaint reporting presence of smoke during treatment with an endoprobe.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Engineering failure analysis could not be performed because the device was not returned for evaluation.No additional information is available at this moment.Iridex will continue to follow-up with the doctor for information regarding patient recovery.
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Search Alerts/Recalls
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