FDA Adverse Event Malfunction Summary report: N

XI 30 ENDOWRIST STAPLER

MDR report key: 8183876 · Received December 20, 2018

Report

Report Number
8183876
Event Type
Malfunction
Date Received
December 20, 2018
Date of Event
October 9, 2018
Report Date
December 18, 2018
Manufacturer
INTUITIVE SURGICAL INC
Product Code
NAY
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

A SINGLE-LUMEN ENDOTRACHEAL TUBE WAS PLACED BY ANESTHESIA. THE MASS WAS DENSELY ADHERENT OR INVADING THE LEFT UPPER LOBE OF THE LUNG. AS SUCH, MULTIPLE FIRINGS OF THE 45 MM BLACK-COLORED UNIVERSAL GIA STAPLER WERE USED TO PERFORM A LEFT UPPER LOBE WEDGE RESECTION OF THE LUNG. GIVEN THE DENSE ADHESIONS OF THE THYMOMA ONTO THE PERICARDIUM, A WIDE PERICARDIAL RESECTION WAS PERFORMED. THE RADICAL THYMECTOMY AND MEDIASTINAL MASS RESECTION WERE COMPLETED. COMPLEXITY: THE OPERATION WAS MORE COMPLEX THAN A STANDARD MEDIASTINAL MASS RESECTION FOR THE FOLLOWING REASONS: THE PATIENT HAD AN ANTERIOR MEDIASTINAL THYMOMA WHICH WAS INVADING THE PERICARDIUM AND THE LEFT UPPER LOBE OF THE LUNG. AS SUCH, ALTHOUGH MOST OF THE OPERATION WAS PERFORMED IN A MINIMALLY INVASIVE FASHION WITH THE USE OF THE ROBOT OR VIDEO-ASSISTED THORACIC SURGERY, ULTIMATELY, DUE TO THE DENSE ADHESIONS AND INVASION OF THE TUMOR INTO THE LEFT UPPER LOBE OF THE LUNG AND PERICARDIUM, AN OPEN APPROACH WITH A PARTIAL UPPER STERNOTOMY WAS REQUIRED TO PERFORM A COMPLETE RESECTION. ACTION: DAVINCI SUPPORT TEAM CALLED AND RESPONDED IN REAL TIME TO THIS EVENT. REUSABLE STAPLER TO BE SEQUESTERED FOR REVIEW. UPDATE TO BE PROVIDED BY DAVINCI TEAM POST EVALUATION OF THIS ROBOT. PER THE CIRCULATING RN WHO REPORTED THIS EVENT, THE PERI-CARDIUM WAS INVOLVED IN THIS PROCEDURE FOR RESECTION AND THE POTENTIAL FOR THIS PROCEDURE TO CONVERT TO AN OPEN CASE WAS A HIGH PROBABILITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1024976 XI 30 ENDOWRIST STAPLER SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL INC XI

Patients

Seq Age Sex Outcome Treatment
1 24455 DA