Model Number 420344-06 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The curved bipolar dissector instrument was requested to be returned, but it has not yet been received by isi for evaluation.Therefore the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the instrument log for the curved bipolar dissector instrument 420344-06 / n10160823-401 associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4) for approximately 2 minutes.The alleged issue was identified on (b)(6) 2021 prior to starting a procedure so the instrument was not used.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.This complaint is being reported due to the following conclusion: the instrument's pin was dislodged.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 prior to starting (pre anesthesia) a da vinci-assisted surgical procedure, when opening the curved bipolar dissector instrument, a loose pin was identified.A backup instrument of a different type was used and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: when the package was opened the loose pin was identified so the instrument was not used for the procedure as it was withdrawn from use.
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Event Description
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Refer to h10/h11 for follow-up information.
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Manufacturer Narrative
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D10 - intuitive surgical, inc.(isi) received the curved bipolar dissector instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.The instrument was inspected and did not find damaged, dislodged, or loose grip pin or clevis pin.The instrument was placed and driven on a test system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The grip pin and clevis pin did not move during the opening and closing of the grip tips.The instrument was fully functional.
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Search Alerts/Recalls
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