Model Number IS3000 A60P9B |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has not received the unit for failure analysis.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.This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.
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Event Description
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It was reported that during a da vinci-assisted prostatectomy procedure, the fuses in the illuminator broke.Another illuminator unit was used to complete the procedure.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: an external illuminator was used to complete the procedure.The procedure was extended 45 minutes and additional anesthesia was administered.There was no report of intra-operative complications.An isi field service engineer (fse) was dispatched to the facility.To resolve the issue the fse replaced the illuminator.The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has received the illuminator involved with this complaint and completed investigation.Failure analysis investigation confirmed the reported failure.The illuminator was installed into the system and failed with no power.
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Search Alerts/Recalls
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