HUGO¿ RAS SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC RADICAL PROSTATECTOMY PROCEDURE; AFTER ATTACHING THE SECURE CADIERE FORCEPS (SCF) AND INSERTING IT INTO THE PATIENT, THE INSTRUMENT DISAPPEARED FROM THE INSTRUMENT BAR, WAS NO LONGER RECOGNIZED BY THE SYSTEM, AND COULD NOT BE USED. THE SCF WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

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.

Additional Manufacturer Narrative

H2) CORRECTION: H5, H8; ADDITIONAL INFORMATION: D4 (UDI #), D9, H4 H3) EVALUATION SUMMARY: MEDTRONIC LED AN EVALUATION OF THE REPORTED SECURE CADIERE FORCEPS AND THE ASSOCIATED DEVICE LOGS. EVALUATION OF THE LOGS INDICATED THAT THE SECURE CADIERE FORCEPS WERE INSERTED INTO THE INTERNAL REGION AND NO MANUAL MODE HAD BEEN REQUESTED. THE INSTRUMENT WAS DETECTED AS DISCONNECTED. THE SECURE CADIERE FORCEPS WAS THEN RECONNECTED A MINUTE LATER AND ENCOUNTERED AN ERROR WHICH LED TO THE REMOVAL OF THE INSTRUMENT. VISUAL INSPECTION OF THE RETURNED SECURE CADIERE FORCEPS NOTED NO CORROSION ON THE ELECTRICAL CONTACTS. THERE WAS NO DAMAGE NOTED TO THE JAWS OR OF THE DRIVE CABLES. FUNCTIONALLY, THE JAWS WERE MANIPULATED INTO MULTIPLE POSITIONS IN ORDER TO INSPECT THE CABLES. THE JAWS WERE ABLE TO ACHIEVE EACH POSITION FULLY WITH NO DIFFICULTY. ELECTRICAL TESTING WAS PERFORMED AND THE SECURE CADIERE FORCEPS WERE READ WITH NO OBSERVED FAILURES. EVALUATION OF THE SECURE CADIERE FORCEPS NOTED NO ABNORMALITIES ASSOCIATED WITH THE REPORTED CONDITION. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A ROOT CAUSE OR SPECULATE ON A PROBABLE ROOT CAUSE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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 RADICAL PROSTATECTOMY PROCEDURE, AFTER ATTACHING THE SECURE CADIERE FORCEPS TO THE STERILE INTERFACE MODULE (SIM) AND INSERTING IT INTO THE PATIENT, THE SECURE CADIERE FORCEPS DISAPPEARED FROM THE INSTRUMENT BAR, IT WAS NO LONGER RECOGNIZED BY THE SYSTEM, AND COULD NOT BE USED. THE SECURE CADIERE FORCEPS WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.