ENDO GRASP

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.

Description of Event or Problem

ACCORDING TO THE REPORTER PRE-OPERATIVELY FOR VET PROCEDURE, THE USER OPENED UP A BRAND-NEW GRASPER, AND THE PLASTIC COATING WAS TORN, AS SUCH THE SURGEON WAS UNABLE TO USE IT. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. CORRECTION: E4 H3. EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE PLASTIC CABLE SHEATH HAD SHEARING DAMAGE. FUNCTIONALLY, THE JAW ROTATION WORKED WITHOUT DIFFICULTY. THE RELEASE LEVER AND JAW TOGGLE FUNCTIONED PROPERLY. THE RATCHET BUTTON FUNCTIONED PROPERLY. THE JAWS ARTICULATED, OPENED AND CLOSED WITHOUT DIFFICULTY. IT WAS REPORTED THAT THE SHRINK WRAP TORN. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE ISSUE CAN OCCUR IF EXCESSIVE MANIPULATION WAS APPLIED TO JAWS OR DEVICE WHEN ARTICULATING. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: ENDOSCOPIC PROCEDURES SHOULD BE PERFORMED ONLY BY PHYSICIANS HAVING ADEQUATE TRAINING AND FAMILIARITY WITH ENDOSCOPIC TECHNIQUES. CONSULT THE MEDICAL LITERATURE RELATIVE TO COMPLICATIONS, HAZARDS AND TECHNIQUES, PRIOR TO PERFORMING ENDOSCOPIC PROCEDURES. 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.