ENDO PADDLE RETRACT

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCTS: 173046 - 173046 ENDO PADDLE RETRACTOR X3, LOT# P4J1135 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 DURING INTRA-OPERATIVE TESTING OF THE TWO PADDLE RETRACTOR, THE SHAFT CRACKED, LEADING TO INCORRECT DEVICE DEPLOYMENT. THE ISSUE OCCURRED DURING THE REMOVAL OF THE DEVICE FROM PACKAGING FOR A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (RYGB) PROCEDURE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE SHAFT OF THE DEVICE WAS BROKEN. IT WAS REPORTED THAT THE INSTRUMENT BROKE. 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 LEVERAGED AND EXPOSED TO AN IMPROPER OR EXCESSIVE FORCE. THE ISSUE OF DAMAGED SHAFT MAY OCCUR WHEN EITHER THE PADDLE RETRACTOR IS RETRACTED WITH THE PADDLE IN A PARTIALLY OPEN STATE; PUSHING THE INTRODUCER FORWARD OVER A PADDLE THAT IS NOT FULLY CLOSED MAY CAUSE STRETCHING AND BREAKAGE OF THE INTRODUCER; OR IF THE PADDLE RETRACTOR IS SUBJECTED TO EXCESSIVE MANIPULATION OR USED FOR LEVERAGE, THESE FORCES MAY CAUSE THE TEARING OF THE COVER/ CLOTH. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.