MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER EXTEND

Model Number 480422-01

Device Problem Entrapment of Device (1212)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/17/2022

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy procedure, application of a vessel sealer extend (vse) instrument that was connected to the e-100 generator resulted with sticking to tissue and bleeding.However, after switching the generator from e-100 to erbe, the surgeon stopped the bleeding with the same vse instrument and completed the procedure.Intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) and obtained the following additional information regarding the reported event: the csr was present during the procedure and discussed the incident with the surgeon after the procedure.During the procedure, the vse instrument worked up until the incident occurred.The surgeon attempted to seal the short gastric vessel near the spleen.After the sealing cycle was completed, the surgeon opened the jaws; however, the short gastric vessel stuck to the instrument and tore.As a result, the vessel was bleeding.The vessel was so small that the csr could not describe the tear.There was some char build-up on the jaws of the instrument.However, there was no time to clean the instrument, as the patient was bleeding.The surgeon asked the or staff to unplug the e-100 and connect the vse instrument to the erbe generator.After that, the surgeon attempted to reseal the vessel with the same vse instrument and resolved the bleeding.It took about 10-15 minutes to stop the bleeding.The surgeon continued to use the same vse instrument for the rest of the procedure.The estimated blood loss per the anesthesiologist was about 300 ml.There was no blood transfusion rendered to the patient.The patient is reported to be covering well.The csr believes the vse instrument would have been discarded as the surgeon used the instrument and completed the procedure.The csr did not have the patient demographics and was unsure if a video recording was available for review.The csr also firmed the following: the e-100 did work without any issues for a while during the surgery, the instrument sealed and cut the vessel with no issues.However, when the surgeon opened the jaws, the tissue was stuck.It was also confirmed that the e-100 had been used in subsequent procedures with no issues reported.

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.Isi has requested the vse instrument for failure analysis investigation but at this time the instrument has not been returned.If additional information is received, a follow-up mdr will be submitted.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted sleeve gastrectomy procedure, the vse instrument that was connected to a e-100 generator began to stick to tissue and as a result, bleeding occurred.However, after switching the generator from e-100 to erbe, the surgeon was able to stop the bleeding with the same vse instrument.The same vse instrument was used to complete the procedure.The cause of the customer reported failure mode is unknown.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• 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: 13802099
• MDR Text Key: 292483567
• Report Number: 2955842-2022-10645
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L92211116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: L92211116 0138
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ISIFA2022-01-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES