HUGO¿ RAS SYSTEM

Additional Manufacturer Narrative

DEVICE EVALUATION: MEDTRONIC IS LEADING AN EVALUATION OF THE REPORTED BIPOLAR MARYLAND FORCEPS (BMF). EVALUATION OF THE FIRST PROVIDED IMAGE SHOWS THE FOLLOWING ERROR MESSAGE ON THE OPERATING ROOM TEAM INTERACTIVE (ORTI) SCREEN OF THE TOWER: "ARM 1 : WARNING : INSTRUMENT WAS ATTACHED WITH TIP BELOW PORT. INSERTION DISABLED. WITHDRAW INSTRUMENT AND CHECK FOR INSTRUMENT DAM AGE.", "ARM 1 : WARNING : INSTRUMENT WAS ATTACHED WITH TIP BELOW PORT. INSERTION DISABLED. WITHDRAW INSTRUMENT AND CHECK FOR INSTRUMENT DAM AGE.", "ARM 1 : DANGER : ARM UNDOCKED. CHECK PORT LATCH. TOUCH DISMISS TO RESUME USE." AND "ARM 1 : WARNING : INSTRUMENT WITHDRAWAL FAILED. REMOVE INSTRUMENT AND PORT TOGETHER, INSPECT FOR DAMAGE. TOUCH DISMISS TO ACKNOWLEDGE.". IN THE SECOND AND THIRD IMAGES PROVIDED IT SHOWS BMF IN WHICH THE PULLEY OF THE INSTRUMENT HAS BEEN DAMAGED AND HAS PARTIALLY COME OUT TOO. ALSO, THE CABLE PUCK OF THE INSTRUMENT HAS BEEN DISLOCATED. IN THE FOURTH IMAGE PROVIDED, IT SHOWS THE SERIAL NUMBER: C23BAD1589 AND THE PRODUCT ID: MRASI0005 OF THE BMF AND THIS SERIAL NUMBER MATCHES TO THE REPORTED SERIAL NUMBER. IN THE FIFTH IMAGE PROVIDED, IT SHOWS THE FOLLOWING ERROR MESSAGES ON THE ORTI SCREEN: "ARM 1: WARNING: INSTRUMENT WITHDRAWAL FAILED. REMOVE INSTRUMENT AND PORT TOGETHER, INSPECT FOR DAMAGE. TOUCH DISMISS TO ACKNOWLEDGE." AND "ARM 1: DANGER : INSTRUMENT ERROR. WITHDRAW NORMALLY. IF WITHDRAWAL FAILS, REMOVE INSTRUMENT/PORT TOGETHER. REPLACE INSTRUMENT TO RESUME.". FURTHER EVALUATION OF THE REPORTED BIPOLAR MARYLAND FORCEPS 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 AT THE END OF A ROBOTIC LAPAROSCOPIC HYSTERECTOMY, THE BIPOLAR MARYLAND FORCEPS (BMF) TRIGGERED AN INSTRUMENT ERROR MESSAGE AND THE SURGEON LOST CONTROL OF THE INSTRUMENT. THE BEDSIDE ASSISTANT WAS UNABLE TO REMOVE THE BMF NORMALLY, SO THE BROKEN INSTRUMENT PROCEDURE WAS USED TO REMOVE IT. THE PROCEDURE WAS ALMOST COMPLETED, SO THE BMF DID NOT NEED TO BE REPLACED. THE ISSUE CAUSED A DELAY OF APPROXIMATELY 2 MINUTES. THERE WAS NO PATIENT INJURY.