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Model Number 480460-09 |
Device Problems
Failure to Form Staple (2579); Difficult to Open or Close (2921)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The surefrom 60 stapler instrument has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided for review.Verification of the product and event details via system logs cannot be performed at this time because there is insufficient product information.This complaint is being reported based on the following conclusion: it was alleged that the sureform stapler failed to unclamp.Medical intervention may be required in the event that the stapler fails to unclamp from tissue when commanded by the user or system.At this time, it is unknown what caused the unclamping event to occur.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
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Event Description
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It was reported that during a da vinci-assisted surgical procedure, the customer had a stapler malfunction and needed to use the emergency release.The procedure was converted to another da vinci system with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
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Manufacturer Narrative
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The surefrom 60 stapler instrument has been returned and evaluated by the failure analysis (fa) team on 4/12/2022.Failure analysis investigations confirmed, but did not replicate the customer reported complaint.Failure analysis found the primary of unclamping failure to be related to the customer reported complaint.The instrument was found to have an unclamp failure based on log review.Error code 22030: "a stapler, sureform 60 failed in its operation on usm3 / failure mode: unclamping failure / general failure / stapler, sureform 60 / sn: (b)(6)]." however, the failure was not replicated during in-house testing.For clarification, the instrument was returned in an expired state.The rfid editor was used to return the instrument to an unexpired state.Once the instrument was reinstalled on an in-house system, it passed initialization.The instrument clamped, fired and unclamped successfully.The instrument was fired using two black 60 reloads.The root cause was not determinable.A review of the instrument log for the surefrom 60 stapler instrument (480460-09/ l90210119 0150) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2022.
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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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