An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.To correct the issue, the fse replaced the e-100 generator.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) has not yet received the replaced generator 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.No image or procedure video was provided.This complaint is being reported based on the following conclusion: the vessel sealer instrument reportedly did not sufficiently complete a seal even though audible beeps from the generator provided a signal that indicated that the seal was complete.The generator used with the vessel sealer instrument and da vinci system is designed to provide a successful confirmation signal to indicate seal completion.Per the description of the complaint, the vessel sealer may have incurred a failure mode that is known to impact sealing effectiveness with no claim or evidence of mishandling/misuse.Deficiencies in sealing may lead to inadequate hemostasis.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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D14 - intuitive surgical, inc.(isi) has received the e-100 generator associated with this complaint and completed investigations.Failure analysis investigations could not replicate the reported issue.When the generator was installed into the in-house test system and tested with a synchroseal instrument, there were no issues observed.The synchroseal functioned properly and was able to cut/seal about 100 times and the e-100 generator functioned properly.
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