Model Number 470545-03 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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The curved tip stapler 45 instrument has not been returned for evaluation.Therefore, failure analysis of the product related to the complaint cannot be performed.A supplemental mdr will be submitted if further information is received.No images or procedure videos of the event were shared.The instrument's lot number was not available so no log review could be completed to confirm procedure date or other related information.This complaint is being reported based on the following conclusion: it was reported that a fragment fell into the patient.All fragments were retrieved and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.
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Event Description
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It was reported that during a da vinci-assisted pulmonary wedge resection-diagnostic surgical procedure, the stapler instrument tip broke while inside the patient.The procedure was completed 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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Event Description
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Refer to h10/h11 for follow-up information.
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Manufacturer Narrative
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Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1 b1 updated from "product problem" to "adverse event and product problem" b2 updated to "required intervention" h1 updated from "malfunction" to "serious injury".
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Search Alerts/Recalls
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