|
Model Number 48360G |
Device Problem
Failure to Form Staple (2579)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Images from the procedure were provided however the images did not seem to fit the description of the alleged incident.Therefore, no conclusion could be drawn from the image review.Intuitive surgical, inc.(isi) has not received the green stapler reload 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 product is returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No procedure video was provided.A log review could not be performed, since the event date is unknown at this time.The intuitive surgical sureform 60, sureform 60 reloads, and other stapler accessories are intended to be used with da vinci surgical systems for resection, transection, and, or creation of anastomoses in general, thoracic, gynecologic, urologic, and pediatric surgery.The device can be used with staple line or tissue buttressing material (natural or synthetic).This complaint is being reported due to the following conclusion: it was alleged that the staple line was incomplete with no claim or evidence of mishandling/misuse.At this time, it is unknown what caused the event to occur.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.
|
|
Event Description
|
It was reported that on an unknown date during a da vinci-assisted sleeve gastrectomy procedure, when the surgeon stapled the stomach with the sureform 60 stapler, the stomach remained open.There was no reported patient harm, adverse outcome, or injury.Per subsequent follow-up information received on 15-june-2021, it was reported that the sureform 60 stapler was inspected prior to use.At the time of the event, the customer was using the green stapler reload.The instrument had been in use for one hour when the issue was identified.There was no gastric injury as a result of the reported issue and no fragments fell inside the patient.The tissue was not exposed to any radiation prior to the procedure and there was no tissue tension or bunching.The surgeon denied experiencing any clamping issue or encountering any obstruction during the procedure.The jaws were not stuck on the tissue when the issue was identified and there were no malformed staples observed.The surgeon sutured the tissue and no leaks were observed.There were no post-operative complications as a result of the issue and the patient has since been discharged.The procedure was not recorded on video.
|
|
Manufacturer Narrative
|
Additional information can be found in the following fields: d9, g3, g6, h2, and h3 product evaluation information can be found in the following fields: h6 and h10 d10-intuitive surgical, inc.(isi) has received the sureform 60 stapler instrument along with the green reload associated with this complaint and completed investigations.Failure analysis investigations could not replicate nor confirm the reported complaint.When the sureform 60 stapler instrument was placed and driven on an in-house system, the instrument passed initialization, recognition, and engagement tests.The sureform 60 stapler instrument moved intuitively with full range of motion in all directions and the jaws opened and closed properly.The instrument clamped, fired, and unclamped successfully twice.The sureform 60 stapler instrument was fired with a sureform green 60 reload both times.No malformed staples or incomplete firing were observed during in-house testing.Visual inspection was performed and no damage was observed.A review of remotefe and dsp logs did not show any failures.The root cause was non-device related factors.Returned with the sureform 60 stapler instrument was the green reload.Failure analysis investigation was completed and upon visual inspection, the reload appeared to be used and fired without any issue.No damage was found to the cartridge.The reload was disassembled in-house for inspection.No damage to the cartridge or the knife was observed.The root cause was non-device related factors.
|
|
Event Description
|
Refer to h10/h11 for follow-up information.
|
|
Manufacturer Narrative
|
This event was initially assessed as a product problem, but has been re-assessed as an adverse event and product problem.
|
|
Search Alerts/Recalls
|
|
|