MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-38

Device Problem Failure to Deliver Energy (1211)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the erbe electrosurgical unit involved with this complaint.However, as of the date of this reported, the failure analysis has not yet been completed.Based on the current information provided, the root cause of the customer-reported failure mode cannot be determined or is unknown.A follow-up mdr will be submitted upon the completion of failure analysis and if additional information is obtained.A review of the system and instrument logs has been performed.There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.Additionally, all instruments used in the case were used in subsequent procedures.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 radical prostatectomy, the erbe generator was not delivering energy, resulting in blood loss.Although the reported blood loss was 30 ml, it is unknown what medical intervention, if any, was administered due to the bleeding.At this time, the root cause of the customer reported failure mode is unknown.

Event Description

It was reported that during a da vinci-assisted radical prostatectomy that the erbe generator was not delivering energy resulting in approximately 30 ml of blood loss.The operating room team power cycled the erbe generator which resolved the issue and the surgeon proceeded with the case.The case was completed robotically.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the erbe electrosurgical unit involved with this complaint.However, as of the date of this reported, the failure analysis has not yet been completed.Based on the current information provided, the root cause of the customer-reported failure mode cannot be determined or is unknown.A follow-up mdr will be submitted upon the completion of failure analysis and if additional information is obtained.A review of the system and instrument logs has been performed.There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.Additionally, all instruments used in the case were used in subsequent procedures.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 radical prostatectomy, the erbe generator was not delivering energy, resulting in blood loss.Although the reported blood loss was 30 ml, it is unknown what medical intervention, if any, was administered due to the bleeding.At this time, the root cause of the customer reported failure mode is unknown.

Event Description

It was reported that during a da vinci-assisted radical prostatectomy that the erbe generator was not delivering energy resulting in approximately 30 ml of blood loss.The operating room team power cycled the erbe generator which resolved the issue and the surgeon proceeded with the case.The case was completed robotically.

Manufacturer Narrative

Additional information can be found in the following fields: d9, g3, g6, h2, h3, h6, and h10.An intuitive surgical, inc.(isi) advanced failure analysis (afa) engineer reviewed the system logs and noted the following: the 3 errors recorded are c-06, m-11, and u-04.All three of these errors are related to the erbe system itself.C-06 is described as ¿system error.Activation request w/o parameter dataset.¿ m-11 is ¿internal timeout.¿ u-04 is ¿out of memory." the erbe generator has been returned and evaluated by isi failure analysis.The reported failure (erbe will not deliver energy) could not be reproduced.The unit was tested using the same instruments but the failure was not replicated.The unit was energized and cauterized and all ports recognized instruments.A visual inspection was performed and the generator was noted to be in good condition.There was no problem detected.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 13099045
• MDR Text Key: 285220110
• Report Number: 2955842-2021-11821
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 381121-38
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2020
• 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: Male