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Model Number 470179-19 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has requested that the monopolar curved scissors instrument be returned for evaluation, but it has not yet been returned.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ 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 video was provided for review.A review of the instrument log for the monopolar curved scissors instrument (part#470179-19/lot# k11211108 0463) associated with this event has been performed.Per logs, the monopolar curved scissors instrument was last used on (b)(6) 2022 on system sk1436.This complaint is being classified as a reportable event due to the following conclusion: it is unknown if a fragment fell inside the patient.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 as unintended fragment(s) falling into the patient may require surgical intervention.
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Event Description
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It was reported that during a da vinci-assisted endometriosis resection surgical procedure, the monopolar curved scissors instrument did not close.No known impact or patient consequence was reported.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.The following remains unknown: the patient and procedure outcome following the alleged issue and if any fragments fell inside the patient.
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has received the monopolar curved scissors (mcs) instrument associated with this complaint and completed investigations.Failure analysis investigations could not replicate nor confirm the customer reported complaint.Failure analysis found the primary failure of mechanical indentations/burrs to the blades to be related to the customer reported complaint.The mcs instrument was found to have blade damage.Both of the blade edges were indented, this can prevent the blades from closing.The mcs instrument was placed on an in-house system, and cut test was performed.The scissors did not cut cleanly through 0.006" latex.The latex got snagged at the scissor tips.The root cause of mechanical indentations/burrs instrument blades is typically attributed to mishandling/misuse.
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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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