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

Model Number IS3000

Device Problem Insufficient Information (3190)

Patient Problem Fluid Discharge (2686)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

Isi has not determined the root cause for the alleged post-operative complications experienced by the patient.If additional information is received a follow-up mdr will be submitted to the fda.Isi has reviewed the site¿s system logs with a procedure date of 03/16/2018.No related system errors were found to have occurred during the surgical procedure.Based on the information provided, this complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted partial nephrectomy procedure, a ct-scan found ¿liquid accumulation outside the part where renal parenchymal suture was performed.¿ as a result, a double-j ureteral stent was placed.However, at this time, the root cause of the post-operative complication is unknown.In addition, there is no allegation that a malfunction of the da vinci surgical system occurred.

Event Description

It was reported that after undergoing a da vinci-assisted partial nephrectomy procedure, the patient developed post-operative fever and a ct-scan found "extrarenal urinary overflow." the ct-scan revealed "liquid accumulation outside the part where renal parenchymal suture was performed" during the da vinci-assisted surgical procedure.As a result, a double-j ureteral stent was placed and the patient's hospitalization was extended.On 03/28/2018, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: there was no allegation or indication that a malfunction of a da vinci system, instrument, or accessory occurred during the surgical procedure.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7434653
• MDR Text Key: 105634934
• Report Number: 2955842-2018-10142
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IS3000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention