Model Number 400498-05 |
Device Problem
Material Deformation (2976)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 02/05/2024 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information provided, the cause of the reported complication cannot be determined.Intuitive surgical, inc.(isi) has not received the stainless steel reprocessing tray lid that was used during this reported event; therefore, failure analysis investigations (fa) has not been performed.An isi clinical development engineer reviewed the provided image and confirmed a protrusion present on the lid of the reprocessing tray and noted that there is a user advisory to inspect the trays prior to use and after use for any defects or damages to mitigate harm.
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Event Description
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It was reported that while opening the box in central processing, a metal piece protruding from the lid of a stainless steel reprocessing tray injured the left index finger of a cleaning staff member.The metal protruding part was located around the edge of the lid, near the latch used for locking.The box was being opened for product inspection and the issue was not identified until after the injury occurred.The injury was described as minor, with a small amount of blood that oozed from the finger and was resolved by applying an unspecified disinfectant and a bandage.The tray had been unused, with no report of patient involvement.The site is requesting a replacement.
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) received the stainless steel reprocessing tray for failure analysis evaluation.Failure analysis investigations confirmed the customer reported complaint of sharp edges.The sterilization tray was found to have a metal part protruding near the latch of the tray's lid.
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Event Description
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Refer to h10/h11 for follow-up information.
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Search Alerts/Recalls
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