MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-43

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root causes of the customer reported failure mode and intra-operative complication cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.No image or video clip for the reported event was submitted for review.System or instrument log reviews could not be performed due to a lack of system, procedure, and instrument detail.This complaint is being reported due to the following conclusion: during an da vinci-assisted cystectomy surgical procedure, the surgeon accidentally stapled part of the rectum due to disorientation of the surgical field.At this time, the severity of the injury, the medical intervention required, and the root cause of the intra-operative issues are unknown.In addition, the cause of the alleged failure mode is unknown.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.

Event Description

It was reported that during a da vinci-assisted cystectomy procedure and after the surgeon had flipped the bladder from the rectum, the surgeon experienced the camera twisting.As a result, the surgeon accidentally stapled a part of the rectum.The surgeon explained that the rectum was a midline structure.However, the surgeon claimed that the rectum then moved away from the midline when the camera was moved.The surgeon indicated that when the dials move on the camera (while controlling the endoscope) disorientation occurs.On 13-apr-2022, intuitive surgical, inc (isi) contacted the surgeon and obtained the following additional information about the event: with the new design of the da vinci xi endoscope, the surgeon claims that the visual field is unstable when the endoscope is moves.The surgeon indicated that the issue occurred at his previous institution.However, the site name was not provided and is unknown at this time.No further additional information was provided.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

On 17-apr-2022, the following additional information was obtained: the surgeon reported, ¿details are provided from the morbidity and mortality meeting discussing the complication of a colleague.During a robotic radical cystoprostatectomy and following developing the posterior plane between the bladder and prostate anteriorly and the rectum posteriorly, this surgeon, during such dissection, twisted the telescope to the rt side to complete such dissection.This twisted the camera to the rt side as well with a shift to the rt in the whole surgical field.The stapler was applied on the rt prostate pedicle, however because of the rt shift of the surgical field with the twist in the camera, surgical field disorientation occurred and the rectum, which is a midline structure shifted to the right, a portion of the anterior wall of the rectum was stapled-reducing the diameter of the rectum by almost 30%.¿ a review of a video provided by the customer was performed by an intuitive surgical, inc.(isi) clinical development engineer (cde) and the following additional information was provided: the video does not show any malfunction of the endoscope and does not show any injury to the patient.To understand the surgeon¿s concerns, it sounds like someone is manually rotating the endoscope at the universal surgical manipulator (usm) during the procedure, which is then disorienting the console surgeon and leading to a surgical error and potential injury to the patient.It would be recommended that the console surgeon control the rotation of the endoscope by themselves, if possible, to reduce any potential for confusion.If a second surgeon must rotate the endoscope manually, then constant communication with the console surgeon is necessary to prevent confusion and patient injury.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 14131839
• MDR Text Key: 294138266
• Report Number: 2955842-2022-11094
• Device Sequence Number: 1
• Product Code: NAY
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-43
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2022
• 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.