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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

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.
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Brand NameDA VINCI
Manufacturer (Section D)
3410 central expressway
santa clara CA
Manufacturer (Section G)
3410 central expressway
santa clara CA
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 
MDR Report Key12550796
MDR Text Key278347184
Report Number2955842-2021-11221
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A