ENDO DISSECT

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND PHOTOS WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE JAWS OR TIP WERE MISALIGNED. AN ARC WAS OBSERVED AT THE TUBE. FUNCTIONAL TESTING FOUND THE JAWS OPENED AND CLOSED WITHOUT DIFFICULTY WHEN APPLIED TO TEST MEDIA. IT WAS REPORTED THAT WHILE OPENING A NEW DISSECTOR PACK, THE SURGEON OBSERVED THAT THE JAWS WERE MISALIGNED. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE MAY OCCUR WHEN THE DEVICE IS ACTIVATED WITH EXCESSIVE FORCE ON THE JAWS AND USED WITH A TWISTING MOTION. 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. 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.

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

IT WAS REPORTED THAT PRIOR TO USE FOR A LAPAROSCOPY SURGERY, WHILE OPENING A NEW DISSECTOR PACK, THE SURGEON OBSERVED THAT THE JAWS/TIP WERE MISALIGNED. THE DEVICE WAS REMOVED, AND ANOTHER NEW DISSECTOR PACK FROM ANOTHER BRAND WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.