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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380652-46
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Urinary Tract Infection (2120); Fluid Discharge (2686)
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the root causes of the patients' reported postoperative complications cannot be determined or are unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. If additional information is received, a follow-up mdr will be submitted. There was no image or video clip supplied for review related to a specific event. 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: within the journal article titled, ¿transvesical approach in robot-assisted bladder diverticulectomy: surgical technique and outcome," it is noted that a patient experienced low abdominal pain after catheter removal and was treated with interertion of a transurethral catheter for an additional 5 days. At this time the root cause of the post-operative abdominal pain is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.
 
Event Description
On 11-mar-2022, intuitive became aware of a "journal of endourology" article titled, ¿transvesical approach in robot-assisted bladder diverticulectomy: surgical ttechnique and outcome¿ (develtere, d. , mazzone, e. , et al. , 2022). The outcomes of 23 patients who underwent a transvesical robot-assisted bladder diverticulectomy (rabd) between march 2015 and may 2020 were analyzed. Within the journal article, post-operative complications involving a da vinci surgical procedure were noted. ¿one patient experienced low abdominal pain after catheter removal which was suspicious for urinary leakage and was treated with insertion of a transurethral catheter for additional 5 days (with complete symptom resolution after catheter removal). One patient developed a uti. No other early postoperative complications were recorded. " additionally, no intra-operative complications were reported and no late post-operative complications were recorded. Isi has reached out to the author to obtain additional information but has not yet received a response.
 
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Brand NameDAVINCI XI
Type of DevicePATIENT 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 Key14059717
MDR Text Key293697897
Report Number2955842-2022-10954
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-46
Device Catalogue Number380652
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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