ENDO GRASP

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AFTER 10 OR 15 MINUTES WHILE USING THE DEVICE UPON GRASPING LIFTED CHOLECYST, THE DEVICE GOT DEFORMED. THE SURGEON REPORTED THAT IT MELT, NO EXCESSIVE LOAD WAS ADDED AND ELECTRICAL CAUTERY DID NOT HIT THE DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES AND THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE BUT NO TISSUE DAMAGE WAS CAUSED. THERE IS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED SHEARING DAMAGE OF THE PLASTIC CABLE SHEATH. IT WAS REPORTED THAT THE INSTRUMENT MELTED. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE MAY OCCUR WHERE AN EXCESSIVE FORCE OR LEVERAGE IS APPLIED TO THE DEVICE WHILE RETRACTING THE CLEVIS ASSEMBLY AND THE CLEVIS BOOT IS SUBSEQUENTLY DAMAGED. THIS SUBSEQUENT DAMAGE MAY RESULT IN IMPROPER RETRACTION AND DEPLOYMENT OF THE JAWS DURING ARTICULATION AND MAY CAUSE SHEARING OF THE PLASTIC CABLE SHEATH. MELTED HOUSING TUB MAY HAVE BEEN CAUSED BY DEVICE COMING INTO CONTACT WITH A CAUTERY INSTRUMENT. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.