|
Model Number 470405-06 |
Device Problem
Break (1069)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 12/04/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The force bipolar instrument has not been returned to intuitive surgical, inc.(isi) for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned for analysis and/or if additional information is received.A review of the logs showed the force bipolar instrument (part #470405-06 / lot #n10200928-0030) was last used on (b)(6) 2020 during this reported procedure with system sk2880.The force bipolar instrument has 10 allotted uses and 6 uses remaining.In addition, a review of the site's complaint history identified no other complaints related to this reported event.An image of the force bipolar instrument related to this event was received.A review of the submitted image was performed and it was confirmed that the jaw of the force bipolar instrument was broken off inside the patient.This complaint is being reported due to the following conclusion: during a da vinci-assisted inguinal hernia repair surgical procedure, it was alleged that one of the jaws of the force bipolar instrument popped off and fell inside the patient.The fragment was retrieved during the same procedure and no additional surgical intervention was required.However, unintended fragments falling inside the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.Although there was no patient harm reported, if the alleged malfunction were to recur it could cause or contribute to an adverse event.
|
|
Event Description
|
It was reported that during a da vinci-assisted inguinal hernia repair surgical procedure, one of the jaws of the force bipolar instrument popped off and fell inside the patient.The surgeon was trying to grab a mesh at the time of the event.It was noted that the jaw of the force bipolar instrument was totally disconnected.The fragment was retrieved during the same procedure with a back-up instrument.The customer replaced the force bipolar instrument with a back-up instrument of the same kind and continued with the case.There are photographic images of the device/fragment(s) available for intuitive surgical, inc.(isi) to review.The procedure was completed with no reported injury.Isi obtained the following additional information regarding the reported event: the force bipolar instrument performed as intended up until it broke.The fragment was visually located and retrieved during the same procedure.No additional surgical procedure was required, and there was no harm to the patient.There were no post-operative tests performed to check for remaining fragments.The force bipolar instrument was reportedly inspected prior to use, and no issues were noted.The force bipolar instrument was in use for 15 minutes prior to the issue.The force bipolar instrument did not make contact with any other instrument or other hard material during the surgical procedure.The fragment(s) did not fall inside the patient during an instrument tip collision.Upon final removal of the force bipolar instrument, there was no resistance through the cannula.The surgical staff did not notice any other damage to the force bipolar instrument or the cannula after the event occurred.The force bipolar instrument is available for return to isi for evaluation.The procedure was performed on a (b)(6) who was born on (b)(6) 1993 and weighed (b)(6).No additional patient-related information was available.
|
|
Event Description
|
Refer to h10/h11 for follow-up information.
|
|
Manufacturer Narrative
|
Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.B1 updated from "product problem" to "adverse event and product problem." b2 updated to "required intervention." h1 updated from "malfunction" to "serious injury.".
|
|
Search Alerts/Recalls
|
|
|