ENDO DISSECT

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD A BENT TIP, THE GREEN COLOR-ADJUSTING DIAL WAS VERY STIFF AND DIFFICULT TO TURN. THE DEVICE DID NOT GRASP PROPERLY AS WELL AND THE JAWS WERE MISALIGNED. THE DEVICE WAS NOT USED AND WAS REPLACED.

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

Additional Information: G3, H3, H6 H3 Evaluation Summary: Medtronic conducted an investigation based upon all information received. The device was not returned, but a photo was available for evaluation. Visual inspection noted that the first image depicts a red square drawn around the rotation knob. The second image depicts the jaws of the device misaligned. The third image depicts the handle of the device. It was reported that jaws misaligned. The reported issue was confirmed. The most likely cause could not be established from the information available. It was also reported that instrument bent, rotation insufficient and instrument did not grasp. The reported issues could not be confirmed. The most likely cause could not be established from the information available. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all Medtronic quality specifications. A secondary review of the device history records found no potentially contributing factors. 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.