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Model Number 470057-08 |
Device Problems
Unintended System Motion (1430); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Based on the claim against the product by the customer noting endoscope would not turn an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and found to have the attached endoscope adapter (aea) damaged of friction issue.The endoscope also had button mechanical damage, discoloration of housing, strain relief on ic housing, and corrosion or physical damage to ic emi fingers.The complaint regarding endoscope would not turn was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.This complaint is being classified as a reportable event due to the following conclusion: it was alleged that the endoscope moved freely with uncontrolled motions.Poor camera control could result in unintuitive motion and subsequent tissue damage.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 proctectomy surgical procedure, the endoscope would not turn into position and would not stay in place.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 date of this report.
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Search Alerts/Recalls
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