MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST VESSEL SEALER EXTEND; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 480422

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Diminished Pulse Pressure (2606)

Event Date 11/23/2021

Event Type  Death  

Event Description

The patient was middle-aged with a history of obesity, hypertension and rectal cancer diagnosed earlier this year.He underwent robotic-assisted abdominoperineal resection.Approximately 1 hour after surgery while in the post-anesthesia care unit he was noted to be unresponsive and pulseless.At that time cpr was initiated.Noted to be in pulseless electrical activity (pea) arrest.Return of spontaneous circulation (rosc) was obtained after two rounds of cpr.The team was concerned for an acute myocardial infarction.The patient was taken to catheterization lab for intervention, and heparin and aspirin were administered for a presumptive coronary thrombus or pulmonary embolism.No evidence of acute blockage of coronary arteries was noted, and repeat hemoglobin measurement showed severe anemia and volume resuscitation with blood products and fluids was continued.An emergency exploratory laparotomy was performed, and 3 to 4 units of blood were noted in the abdomen which was then extensively packed to control the bleeding.However, despite control of the intraabdominal bleeding and transfusion of blood products, return of spontaneous circulation was not achieved.The injuries were deemed nonsurvivable.The patient expired.Subsequent autopsy reveal a patient inferior mesenteric artery where sealant had been used intraoperatively.

• Brand Name: ENDOWRIST VESSEL SEALER EXTEND
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12959804
• MDR Text Key: 281912867
• Report Number: 12959804
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422
• Device Lot Number: M91210901-0363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 18980 DA
• Patient Sex: Male