Catalog Number 8065750918 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2023 |
Event Type
malfunction
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Event Description
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A physician reported that the tube was not connected with the handpiece tightly during the vitrectomy surgery.The product was replaced and the surgery was completed.There was no patient harm.
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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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As a result of an internal review of the file, it was determined that the information provided for this event does not represent a reportable device malfunction.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that the tube was not connected with the handpiece tightly during the vitrectomy surgery.The product was replaced and the surgery was completed.There was no patient harm.As a result of an internal review of the file, it was determined that the information provided for this event tube could not connect with the handpiece tightly due to connector loose issue during surgery, does not represent a reportable device malfunction.
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Search Alerts/Recalls
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