Catalog Number 8065752437 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This report is for the vitrectomy probe component.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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Event Description
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An ophthalmic surgeon reported that the cutter got stuck in the port and pulled the port out.The ophthalmic surgeon reinserted the port to another site; however, the same thing occurred.The product was replaced and the procedure was completed.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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An ophthalmic surgeon reported, that the cutter got stuck in the port.And pulled the port out.The ophthalmic surgeon reinserted the port to another site.However, the same thing occurred.The product was replaced.And the procedure was completed.Additional information was received.The reported informed, that there was no patient harm.
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Manufacturer Narrative
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A sample was not received, at the manufacturing site for evaluation.Therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site.And the device history record review of the lot number provided, indicated the product was processed and released according to the product¿s acceptable criteria.Therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown.Therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected, during the manufacturing process for excessive manufacturing materials on the needle.All assembled probe needle diameters are also 100% tested, for fit into a ring gauge to insure the probe needle does not exceed a trocar opening.Complaints are reviewed, and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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