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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI DA VINCI SURGICAL SYSTEM

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INTUITIVE SURGICAL, INC DA VINCI DA VINCI SURGICAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/04/2021
Event Type  Injury  
Event Description
On 22-nov-2021, intuitive surgical, inc. (isi) became aware of a international journal of urology case reports article titled, ¿endoscopic laser treatment for urine leakage caused by an isolated calyx after robot-assisted partial nephrectomy¿ (inoue, r. , isoyama, n. , et al. , 2021). Within the journal article, a post-operative complication involving a da vinci surgical procedure was noted: "an (b)(6) man underwent robot-assisted partial nephrectomy for the treatment of renal cell carcinoma (ct1bn0m0). Postoperatively, urine leakage was observed and did not improve with conservative measures. Retrograde pyelography and computed tomography revealed that urine leakage originated from the isolated calyx caused by infundibular stenosis. Endoscopic treatment via the transurethral approach was selected to preserve renal function. Ureteroscopy showed that the upper calyx was completely obstructed by the sutures. Therefore, we cut the suture thread using laser, and a ureteral stent was placed in the upper renal calyx. Fluid drainage immediately disappeared after the procedure, and the patient did not lose renal function. " isi has reached out to the author to obtain additional information but has not yet received a response.
 
Manufacturer Narrative
Based on the current information provided, the root cause of the customer reported post-operative complications cannot be determined or is unknown. There is no allegation of a da vinci product malfunction. As a result, no products are expected for return and analysis. 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 instrument detail and lack of specific event/procedure detail. No image or video clip for the reported event was submitted for review. System or instrument log reviews could not be performed due to lack of system, procedure, and instrument detail. Based on the information provided at this time, this complaint is reportable due to the following: within the journal article titled, ¿endoscopic laser treatment for urine leakage caused by an isolated calyx after robot-assisted partial nephrectomy,¿ it is noted that a patient experienced post-operative urine leakage which required additional medical intervention. The cause of the post-operative complication is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.
 
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Brand NameDA VINCI
Type of DeviceDA VINCI SURGICAL 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 Key13029602
MDR Text Key287345676
Report Number2955842-2021-11769
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
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
Date Manufacturer Received11/22/2021
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

Patient Treatment Data
Date Received: 12/17/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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