MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; VISION SIDE SYSTEM, RECONDITIONED

Model Number 380721-01

Device Problem Loss of Power (1475)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Based on the information currently provided, the details of a possible injury remain unknown and, therefore, the cause is not established.The loss of or power was reported to be due to a lightning strike.A review of system logs found the possible related error(s) to the reported power issue experienced by the customer.A power fault related to loss of ac power to the core and a non-recoverable fault 17 was identified.The usage history was reviewed for all the reusable instruments installed throughout the procedure and all were used in subsequent procedures with no reported issues.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 sacrocolpopexy with hysterectomy procedure, the entire or lost power due to a lightning strike.As a result, the da vinci system lost power mid procedure and it was noted that there was a possible injury according to the surgeon.The surgeon elected not to troubleshoot and made the decision to convert to the procedure to traditional laparoscopic surgery.Details regarding the possible injury were not provided.The cause, type, severity, and source of the injury are unknown.

Event Description

It was reported that during a da vinci-assisted sacrocolpopexy with hysterectomy procedure, the system lost power mid- procedure.The system had an unspecified non-recoverable fault and the arms were red.The surgeon elected not to power cycle or attempt to recover and instead, decided to convert the procedure to traditional laparoscopy due to the facility power loss.The surgeon mentioned that there was a possible patient injury; however, no details were provided regarding the potential injury.The intuitive surgical inc.(isi) field service engineer (fse) followed up with the customer about the power loss and was informed that a lightning strike caused the power outage to the entire operating room (or).When the power outage occurred, the patient side cart (psc) reverted to battery backup as designed.When the power was restored, the system booted back up because of the psc still being on and the system generated a non-recoverable error due to the loss of communication to the vision side cart (vsc).The customer power cycled all subsystems, and brought them up together, and the system worked properly.Per the fse, the system was working as intended and no additional action was required.Also, per the fse, during the event, the jaws of an unspecified instrument were stuck on uterine tissue.According to the fse, the surgeon stated that since the uterus was tissue was being removed, he did not want to troubleshoot or use the instrument release key (irk) to release the tissue that was stuck on the instrument.

• Brand Name: DA VINCI XI
• Type of Device: VISION SIDE SYSTEM, RECONDITIONED
• 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: 14840179
• MDR Text Key: 295111189
• Report Number: 2955842-2022-12499
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115343
• UDI-Public: (01)00886874115343
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380721-01
• Device Catalogue Number: 380721
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2018
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White