MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI; GENERATOR,E-100

Model Number 374848-04

Device Problem Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) went onsite to further investigate the reported issue.The fse conducted system inspection, reseated cables and performed a cautery test with no issues identified.The fse was unable to replicate the reported issue.The fse performed system verification and the system was tested and verified as ready for use.Based on the current information provided, the root cause of the customer reported failure mode cannot be determined as the reported issue was not replicated.The two vse instruments involved in this complaint were discarded and are not available for evaluation.Isi has attempted to contact the surgeon to gather additional information regarding the incident.However, as of the date of this report, no new information has been obtained.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was conducted on found no other complaints related to this product.No image or video clip for the reported event was submitted for review.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.Although none of the reusable instruments were reused in subsequent procedures, a site review shows no complaint filed against the instruments.An isi advanced failure analyst (afa) engineer conducted vessel sealer log review and found the following: the first vse instrument (0204) was used on e-100 for approximately 30 minutes on the e-100 generator, where one high initial starting impedance message was recorded.After the 30 minutes of e-100 use, the same instrument was used with an erbe generator for 5 more minutes after which time, the instrument was swapped out for the backup vse instrument (0018).The second backup vse instrument was used for 7 minutes using the erbe generator.No errors observed.Based on the information provided, this complaint is considered a reportable malfunction due to the following conclusion: the vessel sealer instrument reportedly did not sufficiently complete a seal with the e-100 generator 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 e-100 generator 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.There was some mild bleeding seen when the surgeon used the vse on the vaginal cuff.The total amount of bleeding for the procedure was 75 ml and does not meet the criteria of a reportable adverse event.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.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was initially reported by the robotic coordinator that during a da vinci-assisted hysterectomy-benign procedure, the surgeon was trying to control a bleed and it kept bleeding after trying to seal with the vessel sealer extend (vse).The customer stated that they tried two different vse instruments with the same issue.The customer stated that they switched to the erbe generator and the second vse appeared to be working normally with the erbe, but the surgeon opted to use a monopolar curved scissors (mcs) with the erbe.The intuitive surgical, inc.(isi) technical services engineer (tse) reviewed the system's live logs and did not notice any relevant energy related issues present in the logs.The procedure was completed with no reported injury.Isi followed up with the robotic coordinator, who was present for the procedure, and obtained the following information on 19-oct-2021.The vse instrument was not sealing appropriately from the start.When the surgeon used the instrument to seal and cut the vaginal cuff, there was mild bleeding seen from the vaginal tissue when the tissue was cut, although the generator gave the seal complete tone.According to the robotic coordinator, there was tissue effect seen, but not much.There was no calcification of tissue, no previous exposure to chemotherapy/radiotherapy or hard material in the jaws of the instrument during sealing.There was some carbonized tissue in the jaws during the sealing but the sealing effect did not improve even after the carbonized tissue was cleaned.The surgeon tried a backup vse but the issue persisted.The surgeon then used the mcs to cauterize the bleeding tissue.The erbe generator was subsequently used and the sealing function of the first vse was still insufficient but the sealing function of the second vse was back to normal.The surgeon did not have to use the vse anymore and just used the mcs to complete the procedure.Estimated blood loss for the whole procedure was 75 ml.The patient did not need a blood transfusion.The patient was not on any anticoagulant.There was no medical history that contributed to the bleeding seen.Both vse instruments have been discarded.Isi made multiple follow-up attempts to obtain additional information from the surgeon.However, no further details have been received as of the date of this report.

• Brand Name: DAVINCI
• Type of Device: GENERATOR,E-100
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12846917
• MDR Text Key: 285473464
• Report Number: 2955842-2021-11532
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 374848-04
• Device Catalogue Number: 374848
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic