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Model Number 380614-08 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, after docking, the surgeon experienced resistive movement and tried to insert an instrument on arm 2 and it failed with recognition errors on 4 attempts.The patient side manipulator (psm) was disabled and the procedure was completed with 3 arms with no reported injury.
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Manufacturer Narrative
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An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse found error 23019, indicating an observed joint position encoder error on the patient side manipulator (psm).The fse replaced the psm to resolve the reported problem.The psm has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the unit is returned (post engineering evaluation) or if additional information is received.Verification of the event details via system logs cannot be confirmed at this time because there are no events logged for the date provided.No image or video clip for the reported event was submitted for review.
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Manufacturer Narrative
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Additional information can be found in the following fields: d9, g3, g6, h2, and h3.Product evaluation information can be found in the following fields: h6 and h10.The patient side manipulator was returned for failure analysis, and the reported failure (friction (low) along yaw / axis 1) was able to be reproduced during friction testing.The a1 harmonic drive will be replaced as fix.
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Event Description
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Refer to h10/h11 for follow-up information.
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Search Alerts/Recalls
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