Catalog Number 8065752182 |
Device Problems
Loose or Intermittent Connection (1371); Device Slipped (1584)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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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An ophthalmic surgeon reported that the connection of irrigation line and aspiration line was found to be loose; therefore, the connection of handpiece was insufficient.The surgery was completed without product replacement.There was no patient harm.Additional information and product sample have been requested.
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Manufacturer Narrative
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Additional information: the lot specific to this event is not known; therefore, lot history and device history record (dhr) reviews are not possible.Two wet cassettes were returned for this complaint.The white ring of the irrigation luer on sample one would not lock onto the respective handpiece.Using force, the white ring was detached from the black luer.Cyclohexanone was observed on the black irrigation luer barb causing the white ring to stick to the black luer.Sample two met specifications.The root cause of the customer¿s complaint is believed to be an error that occurred during the supplier¿s manufacturing process.When the tubing was inserted, a small amount of solvent got between the black luer and the white ring.Sample two met specifications.The supplier has been made aware of the issue and the sample has been sent to the supplier for additional analysis.Quality assurance will continue to monitor and will take action for future occurrences as deemed necessary.Consumables manufacturing has also been made aware of the issue through the monthly complaint review meeting.(b)(4).
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Manufacturer Narrative
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The lot specific to this event is not known; therefore, lot history and device history record reviews are not possible.Two wet cassettes were returned for this complaint.The white ring of the irrigation luer on sample one would not lock onto the handpiece.Using force, the white ring was detached from the black luer.Cyclohexanone was observed on the black irrigation luer barb causing the white ring to stick to the black luer.Sample two met specifications.Sample one was sent to supplier for further investigation.The root cause of the customer¿s complaint is believed to be an error that occurred during the supplier¿s manufacturing process.When the tubing was inserted, a small amount of solvent got between the black luer and the white ring.Sample two met specifications.The supplier has been made aware of the issue and the sample has been sent to the supplier for additional analysis.Corrective action was initiated at the supplier site.Supplier quality and manufacturing personnel were informed of this issue and notified the production personnel.The work instruction relevant to the adhesive application which caused the customer¿s reported issue was modified to help prevent this issue from occurring in the future.Another action taken was that the solvent dispenser utilized in manufacturing this component was checked with the original validation.Finally, the supplier has increased the visual inspection of this component to 100% visual inspection with steps to look for excessive adhesive.Review of the subsequent three lots run over the next three months from the implementation of the corrective actions showed that no additional problems regarding excessive adhesive were found.(b)(4).
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Search Alerts/Recalls
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