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

Model Number IS4001-01

Device Problem Insufficient Information (3190)

Patient Problem Fever (1858)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, isi has not determined the root cause of the alleged post-operative complications sustained by the patient.A follow-up mdr will be submitted if additional information is received.Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2018.No related system errors were found to have occurred during the surgical procedure.This complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted partial nephrectomy procedure, the patient allegedly developed a post-operative ¿contagious disease with fever.¿ as a result, the patient was administered unspecified ¿transfusion and antibiotics.¿ however, the root cause of the post-operative complications is unknown at this time.

Event Description

It was initially reported that after undergoing an unspecified da vinci-assisted surgical procedure, the patient developed a "contagious disease with fever." the patient was reportedly hospitalized for an extended period of time.However, at this time, the root cause of the patient's post-operative complication is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.On 12/10/2018 and 12/11/2018, intuitive surgical, inc.(isi) obtained the following information regarding the reported event: the patient underwent a da vinci-assisted partial nephrectomy procedure on (b)(6) 2018.There was no report that a malfunction of a da vinci system, instrument, or accessory occurred during the surgical procedure.There were no reported intra-operative complications.On (b)(6) 2018, the patient reportedly developed an unspecified ¿contagious disease with fever.¿ as of (b)(6) 2018, the cause of the disease was unknown and the site was inspecting the case.In addition, as a result of the alleged complications, the patient was administered unspecified ¿transfusion and antibiotics.¿ the patient was still recovering.

• Brand Name: DA VINCI XI SURGICAL SYSTEM
• Type of Device: DA VINCI XI 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: 8201372
• MDR Text Key: 131584449
• Report Number: 2955842-2018-10786
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IS4001-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2018
• 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