ENDO PADDLE RETRACT

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER RESECTION PROCEDURE, THE HAND INSTRUMENT WAS USED TO RETRACT THE LIVER, BUT THE SHAFT BROKE. IT WAS NOTED THAT THE SHAFT WAS MORE FRAGILE AND THE FABRIC WAS THINNER THAN BEFORE. ADDITIONALLY, THE METALLIC STRUCTURES BEHIND THE FABRIC WERE VISIBLE, WHICH HAD NOT BEEN NOTICED PREVIOUSLY. ANOTHER HAND INSTRUMENT WAS USED 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.