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Model Number 400180-14 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 04/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The tip cover accessory will not be returned for evaluation as it was discarded by the customer.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow up mdr will be submitted if additional information is received.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, the mcs tip cover accessory fell off inside the patient.The surgical staff was able to retrieve the mcs tip cover accessory during the same surgical procedure.However, at this time, the root cause of the customer reported failure mode is unknown.
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Event Description
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It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) tip cover accessory came off.The tip cover accessory was retrieved during the same procedure.The procedure was completed with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the clinical sales representative (csr) visited the site and confirmed that the tip cover accessory was installed correctly.The surgeon alleged that the issue may have been caused while the instrument was manipulating heavy adipose (fatty) tissue, which was particularly greasy to the eye.
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Search Alerts/Recalls
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