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

Model Number 380614-05

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); No Information (3190)

Event Date 06/26/2014

Event Type  Death  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported event cannot be determined.If additional information is received, a follow-up mdr will be submitted.Site history review was conducted and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted for review.System error log review was conducted and found that there were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.A review of the instrument logs was also performed.All reusable instruments used in the case were used in subsequent procedures through their respective end of uses and a site review shows no complaint filed against any of the instruments.An isi advanced failure analysis (afa) engineer review was completed and findings revealed that there were 3 vs_cut_failed events that occurred during the procedure due to a partial cut.This is not an instrument issue or malfunction.The partial cuts were most likely due to cutting with too much tissue in the jaws, cutting across a hard object, or cutting with the jaws too far open.There were no sealing errors, blade jammed errors, or homing errors that would be indicative of an instrument failure.There were no recorded engagement or recognition errors for the other tools in use during the procedure.There were two occurrences of a 40067 (msc communication error) prior to the procedure, and the ¿sterile adapter (sa) sensor missing¿ error thirteen minutes prior to the end of the procedure and no instrument was attached at the time of the error, likely indicating that it occurred as the customer was removing the sas and shutting down.Medical review from an isi medical safety officer was completed and findings were as follows: from the information provided in the description of event, a (b)(6) year-old female patient underwent a da vinci-assisted radical cystectomy procedure on (b)(6) 2014.The patient was noted to have a right common femoral vein deep vein thrombosis on (b)(6) 2014.Additionally, the patient was noted to have mild bilateral pelvicalyceal system dilation and retroperitoneal adenopathy.The patient expired on (b)(6) 2014.The plaintiff¿s attorney alleged that the da vinci system was ¿recalled¿ and that the product was ¿not up to par.¿ from the information provided, it is not clear as to why the plaintiff¿s attorney alleges that the da vinci system was ¿not up to par.¿ based upon the ¿post-operative¿ report on (b)(6) 2014, the patient had a diagnosis of a right common femoral vein deep vein thrombosis and retroperitoneal adenopathy.There is no information in the description of event regarding the treatment of the right common vein deep vein thrombosis.Moreover, the report of retroperitoneal adenopathy suggests that patient had metastatic disease.The diagnosis of metastatic disease best fits the limited clinical information that was provided in the event description.No information is provided in the description of the event that would suggest that the da vinci system was not functioning correctly.Based on the information provided at this time, this complaint is reportable due to the following: a (b)(6) year old female patient, with a history of bladder cancer and chemotherapy, underwent a da vinci-assisted radical cystectomy procedure performed on (b)(6) 2014 and subsequently expired on (b)(6) 2014.According to the plaintiff¿s attorney, the family alleged that the isi da vinci¿s system was recalled and that the product was, ¿not up to par¿ with multiple unspecified infractions and unspecified malfunctions that caused her death.At this time, the cause(s) of the patient¿s alleged operative and/or post-operative complications and subsequent death are unknown.Due to the nature of the complaint (litigation), follow-up was not performed to attempt to obtain additional patient-related information.Due to lack of product information, udi and mfg date were unavailable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.Recall (if recall number is given) is not applicable.

Event Description

As part of a legal dispute, intuitive surgical, inc.(isi) received information regarding a (b)(6) year old female patient, with a history of bladder cancer and chemotherapy, who underwent a da vinci-assisted radical cystectomy procedure performed on (b)(6) 2014 that completed without complications.A post-operative report on (b)(6) 2014 recorded bilateral airspace disease at lung bases most likely atelectasis, no significant effusions were seen, and the following impressions were noted: status post bilateral stent placements with mile bilateral pelvicalyceal system dilation, right worse than left, retroperitoneal adenopathy, increased density in the right common femoral vein compared to the left with increased edema in the right lower extremity suggestive of deep vein thrombosis (dvt).On (b)(6) 2014 the patient subsequently expired.The plaintiff¿s attorney alleged that the isi da vinci¿s system was recalled and that the product was, ¿not up to par¿ with multiple unspecified infractions and unspecified malfunctions that caused her death.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10947777
• MDR Text Key: 219762672
• Report Number: 2955842-2020-11297
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380614-05
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Death
• Patient Age: 79 YR