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

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.".

• Brand Name: DA VINCI
• Type of Device: DA 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 Key: 8509536
• MDR Text Key: 141779955
• Report Number: 2955842-2019-10268
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/12/2019
• 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 Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Required Intervention; Disability