MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; PATIENT SIDE CART

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Urinary Tract Infection (2120); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the reported incidents cannot be determined or is unknown.There was no report or allegation from the customer of a deficiency of the da vinci system, instrumentation, or accessories associated with the reported incident.Therefore, there are no products expected for return to intuitive surgical, inc.(isi) for failure analysis evaluation.Isi has attempted to follow-up to gather additional information.However, as of the date of this report, no new information has been obtained.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was unable to be conducted at this time due to lack of system and instrument detail, lack of event/procedure detail, as well as a confirmed site location.No image or video clip for the reported event was submitted for review.Unable to conduct system or instrument log review due to lack of site, system, procedure, and instrument detail.While there is limited information about each event in order to provide a complete report for each event, and there is no specific allegation to investigate, the event meets the criteria of a reportable adverse event as it was alleged within the clinical article that there were various complications for which medical intervention was unknown and a reoperation was cited.It is unknown if the patient's comorbidity/ comorbidities or any other pre-existing conditions may have contributed to the alleged events.At this time, the root cause of the complications are unknown.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Multiple product information are unknown due to limited product information being provided.Due to lack of product information, (510k no.), and (mfg date) are not available.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

On 03-sep-2021, intuitive surgical, inc.(isi) became aware of a journal of minimally invasive gynecology article titled, ¿surgical outcomes of hysterectomy via robot-assisted versus traditional transvaginal natural orifice transluminal endoscopic surgery¿ (koythong, t., thigpen, b., et al., 2021).Within the journal article, a retrospective chart review of a ¿total of 114 patients with benign gynecologic indication for hysterectomy¿ was cited.This study involved t-vnotes or r-vnotes hysterectomy performed by a single minimally invasive gynecologic surgeon in the study period of january 2017 and october 2020.79 patients underwent t-vnotes hysterectomy, and 35 patients underwent robotic r-vnotes hysterectomy with an unspecified da vinci xi system.Within the journal article, in the robotic group of 35 patients, 6 intraoperative and postoperative complications were noted: 3 patients had a urinary tract infection, 1 patient had bladder injury, 1 patient had a superficial surgical site infection, and 1 patient had a reoperation.Isi has reached out to the author to obtain additional information but has not yet received a response.

Manufacturer Narrative

 d15 - intuitive surgical, inc.(isi) received additional information from the article author, a physician, as follows: ¿the complications are not related to any surgical platform".

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• Type of Device: PATIENT SIDE CART
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 12550796
• MDR Text Key: 278347184
• Report Number: 2955842-2021-11221
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES