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Model Number 174317 |
Device Problem
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 04/03/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during a laparoscopic colon surgery, on managing the descendant colon, the surgeon forced the device because the tissue was very hard.The device got twisted and the screw between the jaws of the grasper fell into the cavity of the patient.The surgeon managed to recover and take out the screw.There was no patient injury.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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