Model Number 400180-14 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Isi has requested the monopolar curved scissors (mcs) tip cover accessory to be returned for evaluation.However, as of the date of this report, isi has not received the product.Therefore, the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.The customer reported complaint does not itself constitute an mdr reportable event; however, evidence of arcing found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.
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Event Description
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It was reported that after successfully completing a da vinci-assisted surgical procedure, the customer inspected the instruments and accessories and found a crack on the monopolar curved scissors (mcs) tip cover accessory.The reporter was unable to specify how the mcs tip cover accessory was damaged.There was no report of a fragment falling into the patient.No known impact or patient consequence was reported.Intuitive surgical inc.(isi) obtained the following additional information regarding the reported event: the mcs tip cover accessory was installed into the mcs instrument using an installation tool.The mcs instrument operated without issue and no arcing was observed during the procedure.
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) tip cover accessory involved with this complaint and completed the device evaluation.Visual inspection revealed a tear at the mouth of the tip cover.The tear measuring approximately 0.009¿ to 0.048¿ in length was axially aligned with the tip cover.This observation (tears at the mouth) are most commonly caused by repeated thermal and mechanical stresses sustained by the tip cover.The investigator indicated no signs of thermal damage.
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Event Description
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Refer to additional information for follow-up.
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Search Alerts/Recalls
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