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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
Device Problem Insufficient Information (3190)
Patient Problem Incontinence (1928)
Event Date 04/14/2011
Event Type  Injury  
Manufacturer Narrative
Isi has attempted to contact the surgeon to obtain additional information regarding the reported event. However, as of the date of this report, no new information has been obtained. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. At this time, the specific da vinci surgical system used during the radical prostatectomy procedure is unknown. If additional information is received, a follow-up mdr will be submitted. This complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted radical prostatectomy procedure, the patient claimed that he has been ¿completely incontinent. ¿ however, at this time, the root cause of the post-operative complication is unknown. There is no allegation that a malfunction of a da vinci surgical system occurred.
 
Event Description
It was reported that after undergoing a da vinci-assisted prostatectomy procedure on (b)(6) 2011, the patient claimed that he has been "completely incontinent. " according to the patient, the surgeon¿s operative report noted no complications. Per the patient, a nursing note indicated he had ¿extraordinarily strong pain in the abdominal cavity after the operation. ¿ the patient was discharged on (b)(6) 2011, with a ¿lying bladder catheter. ¿ the catheter was removed on an unspecified date at a rehabilitation clinic and ¿clear urinary incontinence was observed. ¿ four weeks post-operatively, the patient claimed that ¿20-25 urinary catheters were needed per day. ¿ six months post-operatively, the patient indicated that 15 catheters were needed. On (b)(6) 2012, the patient reportedly underwent ¿urodynamic testing¿ by a physician at another hospital. The patient indicated that the physician noted the following in his medical report: ¿there¿s complete incontinence after radical prostatectomy with davinci. ¿ in relation to a low filling capacity of the bladder, the patient questioned as to whether "serious errors were made in the reconstruction of the bladder neck. ".
 
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Brand NameDA VINCI
Type of DeviceDA VINCI SURGICAL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale CA 94086
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale CA 94086
Manufacturer Contact
pat flanagan
950 kifer rd.
sunnyvale, CA 94086
4085232100
MDR Report Key8509536
MDR Text Key141779955
Report Number2955842-2019-10268
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 03/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2019
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

Patient Treatment Data
Date Received: 04/12/2019 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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