HUGO¿ RAS SYSTEM

Additional Manufacturer Narrative

PRELIMINARY DEVICE EVALUATION: MEDTRONIC IS LEADING AN EVALUATION OF THE REPORTED BIPOLAR FENESTRATED GRASPER (BFG). EVALUATION OF THE DEVICE DATA INDICATES THE BFG WAS ATTACHED TO STERILE INTERFACE MODULE (SIM) SN: (B)(6). THERE WAS AN ERROR CODE ¿MOTOR POSITION LIMITS¿ TRIGGERED AS AN AFTER EFFECT OF THE INSTRUMENT JAW BREAK. THE SYSTEM DOES NOT DIRECTLY LOG THE PHYSICAL STATE OF THE INSTRUMENT. THE USE LIFE OF THE INSTRUMENT WAS THREE HUNDRED AND THIRTY-THREE MINUTES WITH A USE COUNT OF FIVE AT THE TIME OF FAILURE. REVIEW OF THE PROVIDED IMAGE NOTES TWO IMAGES AND A VIDEO WERE PROVIDED. THE FIRST IMAGE SHOWS A BFG WITH COMPLETELY BROKEN JAWS AND ONE JAW IS PLACED BESIDE THE INSTRUMENT. THE SECOND IMAGE SHOWS A VIEW OF THE DISTAL END OF THE BFG WITH REFERENCE ID (B)(4) AND SERIAL NUMBER (B)(6) WHICH MATCHES THE REPORTED INFORMATION. A 00:28 SECOND VIDEO WAS SHARED IN WHICH THE BFG JAW WAS BROKEN WHILE HANDLING THE SUTURE NEEDLE AT 00:10 SECOND TIME STAMP AND THE PROCEDURE WAS STOPPED. FURTHER EVALUATION OF THE REPORTED BIPOLAR FENESTRATED GRASPER IS STILL PENDING, AND THE INVESTIGATION IS NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REGULATORY REPORT WHEN THE INVESTIGATION IS COMPLETE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, WHILE SUTURING THE PERITONEUM FOLLOWING MESH INSERTION, THE SUTURE NEEDLE BECAME CAUGHT ON THE TIP OF THE BIPOLAR FENESTRATED GRASPER. THE GRASPER TIP SUBSEQUENTLY BROKE OFF AND FELL INTO THE PATIENT¿S ABDOMINAL CAVITY. THE PROCEDURE WAS CONVERTED FROM ROBOTIC TO LAPAROSCOPIC TO ALLOW RETRIEVAL OF THE BROKEN TIP. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED, AND THE BIPOLAR FENESTRATED GRASPER WAS REMOVED IN ACCORDANCE WITH THE BROKEN INSTRUMENT PROCEDURE. THE PROCEDURE WAS THEN COMPLETED LAPAROSCOPICALLY. PRIOR TO CLOSURE, THE RETRIEVED TIP AND THE INSTRUMENT WERE EXAMINED TO CONFIRM THAT ALL COMPONENTS HAD BEEN RETRIEVED. THERE WAS NO PATIENT INJURY.