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Model Number 471172-17 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The instrument was found with thermal damage at the yaw pulley.Black char marks were observed at the grip base.Any material missing is likely to be thermally induced rather than mechanically induced.The root cause is attributed to mishandling/misuse.The electrical continuity test still passed and there was no insulation damage observed to the conductor wire.A review of the device logs for the maryland bipolar forceps (part# 471172-17 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the instrument was last used on (b)(6) 2022.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.Failure analysis confirmed thermal damage to the bipolar yaw pulley.The root cause of this failure is attributed to user mishandling and misuse.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 during a da vinci-assisted prostatectomy (radical extraperitoneal without lymphadenectomy) surgical procedure, the maryland bipolar forceps instrument had thermal damage on the insulator.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the hospital's distributor and obtained the following additional information: it is unknown if the damage was identified prior or after reprocessing.No inspection was performed prior to reprocessing.At this time, the source was unable to provide additional information.
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Search Alerts/Recalls
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