Intuitive surgical inc.
Has not received the cannula seal accessory for failure analysis.
Therefore, the root cause of the customer reported failure mode cannot be determined.
If additional information is received, a follow-up mdr will be submitted.
This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, a piece from the cannula seal accessory was missing and it is unknown if it fell inside the patient.
The missing piece was not found during the procedure.
At this time, the location of the missing piece is unknown and it is unclear if any piece of the cannula seal was retained inside the patient.
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It was reported that during a da vinci-assisted prostatectomy procedure, the customer noted a missing green cannula seal.
The customer was unsure if the cannula seal was missing at the start of the procedure or if during the procedure the cannula seal fell inside the patient.
The customer contacted the intuitive surgical, inc.
(isi) technical support to inquire if the cannula seal was x-ray detectable and was informed that it was radiolucent.
On (b)(4) 2018, isi obtained the following additional information from the registered nurse (rn) who was present during the surgical procedure: she indicated that the cannula seal was not inspected prior to starting the procedure.
They noted that gas was escaping when they inserted the trocar, they removed the trocar with the cannula seal and noted that the clear part of the cannula seal was missing.
They searched for the missing part inside the patient but could not find the missing cannula seal.
They don't know if the cannula seal fell inside the patient or if it was missing prior to starting the procedure.
They replaced the cannula seal and the procedure was completed successfully.
There were no report of patient harm, adverse outcome or injury.
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