MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI

Model Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Vascular Problem (4441); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/23/2021

Event Type  Death  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.Unable to perform site complaint history review as the site name/location is unknown.No image or video clip for the reported event was submitted for review.Customer information is unknown.Unable to perform a review of the instrument logs due to lack of information on file at this time.Unable to perform a review of the system error logs due to lack of information on file at this time.An isi medical safety officer conducted a medical review and found the following: the patient with a 12-year history of diabetes mellitus, hypertension, and uterine adenocarcinoma s/p hysterectomy underwent right hemicolectomy for an appendiceal adenoma suspicious for cancer.Post-operatively, the patient developed hypotension, respiratory distress and cardiac arrest.The patient was resuscitated and transferred to the intensive care unit.Laboratory studies revealed a decrease in the patient¿s hgb level.The patient was transfused 3 units of packed red blood cells.The patient returned to the operating room for an exploratory laparotomy.During the exploration, it was discovered that the patient was bleeding from the ileocolic vessel.The vessel was ligated.Upon completion of the exploration, the patient returned to the intensive care unit.The patient¿s condition continued to worsen resulting in the patient¿s expiration.From the information in the description of events, it is unclear as to the cause of the bleeding from the ileocolic vessel.At this time, there is no evidence of a product issue that would be classified as a reportable malfunction or evidence that an isi device malfunctioned in a way that could contribute to an adverse event.However, at this time, the cause(s) of the patient¿s alleged operative and/or post-operative complications and subsequent death are unknown.The specific alleged failure mode is also unknown.Blank mdr fields: unable to conduct follow-up due to lack of site detail and contact information, therefore the patient information is unknown.Outcomes attributed to adverse event: is blank because the exact date of the patient's death was not provided.The expiration date is not applicable.Product information is not available because specific product details were not provided.Implant date (2020 reports) is blank because the product is not implantable.Date rec¿d by mfr (2020 reports) and device manufacture date are unknown because specific product information was not provided.Initial reporter name and address is unknown because the site and contact information were not provided.Pma/510k (2020 reports), adverse event, recall (if recall number is given) (2020 reports), and correction/removal number (2020 reports) are not applicable.

Event Description

On 5-may-2021, intuitive surgical, inc.(isi) received mw5100203 stating: ¿a (b)(6) y/o female with a history of 12dm.Htn.Uterine adeno cancer s/p hysterectomy (2016), hx of appendiceal adenoma seen on endoscopy that was suspicious for malignancy underwent a robotic assisted lap right hemicolectomy on (b)(6) 2021.On (b)(6) 2021 the patient became hypoxic and cardiac arrested.The patient underwent three rounds of cpr before obtaining rosc.The patient was transported to icu, and three units of emergency released prscs were transfused, due to a profound drop in her hgb, the patient remained hemodynamically unstable and a decision was made to return to the operating room for an exploratory laparotomy.In the operating room, the ileocolic artery was found to have a pulsatile bleed and was subsequently ligated.On return to the icu, pt.Remained hemodynamically unstable with worsening hypoxia.The patient required increased pressure support throughout the day.On (b)(6) 2021 the patient¿s condition continued to worsen.Abdominal compartment syndrome was suspected and the decision was made by the icu team to re-open the abdomen at the bedside.Upon entry into the abdomen, 1000 ccs of thin sanguinous fluid was evacuated.The bowel was extremely dusky with patchy areas of ischemia.The mesentery was congested with hemorrhagic congestion.Everything was gray and dusky.No obvious source of hemorrhage was identified.There was a feculent odor, but no obvious colon or small bowel injury.At this time, the aorta was manually occluded due to a loss of pulses.Three units of blood were given bilateral chest tubes were placed.After multiple rounds of epi, the patient expired.There was a large right side pneumothorax and 100-200 ccs of serosanguinous fluid was evacuated.Expired (b)(6) 2021 at 23:32 in the sicu.¿ isi was unable to follow-up to obtain additional information related to the event because no hospital or contact information was included in the report.

• Brand Name: DA VINCI
• Type of Device: DA VINCI
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11906041
• MDR Text Key: 253454789
• Report Number: 2955842-2021-10586
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1