|
Model Number 471205-17 |
Device Problem
Difficult to Remove (1528)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/07/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that during a da vinci-assisted low anterior resection, the instrument was stuck together in the cannula and could not be removed.The site replaced the instrument and completed the procedure as planned with no report of patient harm, adverse outcome or injury.Follow-up has been performed to request additional information related to the reported event.However, as of the date of this report, no further details have been received.
|
|
Manufacturer Narrative
|
Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument and performed a device evaluation.Failure analysis confirmed the reported issue.The instrument was found to have the main tube broken.A piece measuring proximately 0.113¿ x 0.110¿ in size, was not returned with the instrument.As a result of the broken main tube, the instrument was returned with a cannula and a cannula seal stuck.The root cause of broken instrument main tube is typically attributed to mishandling/misuse.A review of the device logs for the fenestrated bipolar forceps (part# 471205-17 | lot-sequence# k14210906-0218) associated with this event has been performed.Per this review of the logs, the fenestrated bipolar forceps was last used on (b)(6) 2022 during a hysterectomy ¿ benign on system serial# (b)(4).No investigation required as no image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.
|
|
Search Alerts/Recalls
|
|
|