MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FENESTRATED BIPOLAR FORCEPS

Model Number 471205-17

Device Problem Difficult to Remove (1528)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

Isi field service engineer (fse) investigation has been completed.The fse followed up with the customer and asked if she was able to observe how the instrument was stuck.The customer informed fse the issue was the fenestrated bipolar instrument.They tried another instrument on arm #2 with no issues.When they tried with the original instrument, it got stuck again.The fenestrated bipolar instrument has been removed from circulation by the customer.Fse asked the customer if the release buttons on instrument were not working and the customer confirmed that they were not and it required them to manually release it.Issue was confirmed to be related to the instrument and not the system.The tse reviewed the site¿s system logs.No related system errors were found to have occurred during the surgical procedure.No image or video recording was available for review.This complaint is reportable due to the following: during the procedure, there was no energy from the fenestrated bipolar instrument.As a result, the customer attempted to swap the fenestrated bipolar instrument; however, the staff could not remove the device from the arm.As the there was a bleed that needed to be addressed immediately, the surgeon converted the procedure to a laparoscopic procedure.On a field evaluation it was confirmed that the issue was with the instrument and not the system arms.Since the instrument has not been returned to isi for evaluation, the cause of the reported issue is unknown.

Event Description

It was reported that during a da vinci-assisted myomectomy surgical procedure, there was no energy from the fenestrated bipolar instrument.Intuitive surgical, inc.(isi) contacted the surgeon and the site's robotics coordinator and obtained the following information regarding the reported event: during the initial phase of the procedure, during dissection of the uterus, the surgeon used the fenestrated bipolar for coagulation.However, there was no energy delivered.As a result, the customer attempted to swap the fenestrated bipolar instrument; however, the staff could not remove the device from the arm.The system did not generate any messages, and she was informed that they would have to restart the system.Although there was no significant bleeding, she wanted to address the bleed immediately.The patient had a bleeding disorder and was on a blood thinner.In addition, before the procedure, the anesthesiologist had administered a heparin shot.Hence, she did not want to wait and call an isi technical support engineer (tse) for assistance or use the fourth arm.She was comfortable converting the procedure to laparoscopic surgery.After the conversion, the bleeding was addressed by cauterization.The surgeon confirmed the patient is reported to be recovering well with no issues.The fenestrated bipolar instrument on arm #2 was undocked with the instrument still attached.Tse assisted the caller with removing the stuck instrument from arm #2.The robotics coordinator stated that even if there were a video recording of a procedure, they would not provide a copy for review.She also mentioned that it was determined that this fenestrated bipolar instrument was an issue in a previous surgery and should not have been in circulation after reprocessing.She could not provide additional details regarding that.The tse recommended that the site label this instrument not for use and return it to isi.However, it was stated that it was unlikely they would return the instrument.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: 13609265
• MDR Text Key: 290932983
• Report Number: 2955842-2022-10373
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K11211129
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: K11211129 0156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2021
• 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 Sex: Female