YASARGIL VARIO A.FCPS.STD.TI.90/220MM

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: FAILURE DESCRIPTION- THE PRODUCT ARRIVED IN A DECONTAMINATED CONDITION. VISUAL INVESTIGATION - WE MADE A VISUAL INSPECTION AND WE FOUND THAT THEY WERE IN A VERY USED CONDITION. ADDITIONALLY WE DETECTED VISIBLY DAMAGED APPLIER JAWS. WE MADE A FUNCTIONAL TEST OF THE LOCK. HERE WE DISCOVERED NO ERROR. FURTHERMORE WE FOUND ATS LABELING. WE MADE A FUNCTIONAL TEST OF THE THIRD INSTRUMENT; DURING RELEASE OF THE LOCK WE DETECTED AN ERROR. THE LOCK CANNOT BE RELEASED; FURTHERMORE THE INSTRUMENT WAS SENT TO THE PRODUCTION DEPARTMENT FOR FURTHER TESTING. TEST W1 AND W2 NOT TRUE TO GAUGE. THE TONGS HAVE DELIVERED THE TEST CLIP AFTER OPENING. DUE TO THE SOMETIMES EXTREMELY LONG OPERATING TIME/USAGE OF THE COMPLAINED CLIP APPLICATOR TONGS, IT MAY HAPPEN THAT THE ACCURACY OF THE GAUGE IS NOT GUARANTEED. THERE WAS NO PRODUCTION ERROR. BATCH HISTORY REVIEW - THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. CONCLUSION AND ROOT CAUSE - THE ROOT CAUSE OF THE PROBLEM IS MOST LIKELY MAINTENANCE AND USAGE RELATED. RATIONALE - ACCORDING TO THE QUALITY STANDARDS A MATERIAL DEFECT OR PRODUCTION PROBLEM CAN BE EXCLUDED. INVESTIGATIONS HAD LED TO THE LIKLIHOOD THAT THE VISIBLY DAMAGED APPLIER JAWS WERE CAUSED BY IMPROPER HANDLING OR IMPROPER MAINTENANCE. WE ALSO FOUND IT LIKELY THAT THE LOCK WAS BENT BY THE SAME CAUSES. THIS COULD LEAD TO AN UNRELEASED LOCK AND THEREFORE THE INSTRUMENT FAILED TO RELEASE THE CLIP. ALSO, ACCORDING TO RESULTS FROM THE PRODUCTION DEPARTMENT, SPECIFICATIONS INCLUDED THE FOLLOWING: COLOR, FORM, MATERIAL, FUNCTION, GAUGE ACCURACY AND DIMENSIONS CORRESPOND TO THE WORK PLAN. THE CURRENT STATE WAS RECORDED AS FOLLOWS: THE INITIAL SPECIFICATIONS CORRESPOND TO THE WORK PLAN BUT THE W1 AND W2 WERE NOT TRUE TO GAUGE. ALSO, SEE ABOVE INVESTIGATION RESULT RELATED TO THE TONGS. TWO OF THE THREE PLIERS WERE REPAIRED IN 2013. IT WAS FOUND THAT TWO OF THE THREE PLIERS HAD AN ILLEGIBLE BUT RECOGNIZABLE STAMP. FURTHERMORE, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE FOLLOWING POINTS SHOULD BE OBSERVED: SAFE HANDLING - PRIOR TO EACH USE, INSPECT THE PRODUCT FOR LOOSE, BENT, BROKEN, CRACKED, WORN, OR FRACTURED COMPONENTS - DO NOT USE THE PRODUCT IF IT IS DAMAGED OR DEFECTIVE - SET IT ASIDE IF IT IS DAMAGED - REPLACE ANY DAMAGED COMPONENTS WITH SPARE PARTS OPERATING THE PERMANENT LOCKS - SOME CLIP APPLIER FORCEPS VARIANTS ARE FITTED WITH A LOCK TO ENGAGE A CLIP TRANSFER VARIO CLIP APPLIER FORCEPS - THE ADJUSTING PLATES ALLOW CLIPS OF THE CLIP APPLIER FORCEPS CAN BE USED FOR PARALLEL ALIGNMENT OF THE APPLIER JAWS INSPECTION, MAINTENANCE, AND CHECKS - AFTER EACH COMPLETE CLEANING, DISINFECTING, AND DRYING CYCLE, CHECK THAT THE INSTRUMENT IS DRY, CLEAN, AND OPERATIONAL AND FREE OF DAMAGE (E.G. BROKEN INSULATION, OR CORRODED, LOOSE, BENT, BROKEN, CRACKED, WORN, OR FRACTURED COMPONENTS) CHECK THAT THE DEVICE FUNCTIONS PROPERLY IMMEDIATELY PUT ASIDE DAMAGED OR INOPERATIVE PRODUCTS AND SEND THEM TO AESCULAP TECHNICAL SERVICES (ATS), SEE TECHNICAL SERVICES NO CAPA NECESSARY.

Additional Manufacturer Narrative

AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. INVESTIGATION ON-GOING; THIS IS A PRELIMINARY INVESTIGATION. THE PRODUCT HAS RECENTLY BEEN RETURNED; WHEN THE FINAL EVALUATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NO PICTURE AT HAND. THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. BASED ON THE INFORMATION AVAILABLE IT IS HARDLY POSSIBLE TO DETERMINE AN EXACT CONCLUSION AND ROOT CAUSE. WE ASSUME THAT THE CAUSE OF THE FAILURE IS NOT PRODUCT RELATED. THE ROOT CAUSE COULD BE USAGE OR MAINTENANCE RELATED. RATIONALE: IN LIGHT OF THE LACK OF INFORMATION RECEIVED, IT IS NOT POSSIBLE TO DETERMINE AN EXACT CONCLUSION AND ROOT CAUSE FOR THE MENTIONED FAILURE. ACCORDING TO THE QUALITY STANDARD A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. THERE IS THE POSSIBILITY FOR A USAGE ERROR DUE TO AN IMPROPER HANDLING WITH NON-PARALLEL ALIGNMENT OF THE APPLIER JAWS. POSSIBLY THE APPLICATION JAWS MAY ALSO BE DEFECTIVE DUE TO IMPROPER HANDLING OR TO IMPROPER MAINTENANCE. ANOTHER REASON COULD BE A DEFECTIVE LOCK, WHICH MEANS THAT THE LOCK CANNOT BE RELEASED. THESE CAUSES COULD HAVE LED TO AN ERROR IN RELEASING THE CLIP. FURTHER INVESTIGATIONS WILL BE PERFORMED ON THE RETURNED PRODUCT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN INTRAOPERATIVE ISSUE WITH THE BRAIN ANEURYSM APPLIER. DURING CEREBROVASCULAR SURGERY, THE APPLIER FAILED TO RELEASE THE CLIP PROPERLY AND CAUSED A TEAR ON THE VESSEL. THE ANEURYSM APPLIER WITH THE CLIP WAS BEING ADJUSTED ON THE VESSEL WHEN IT OCCURRED. THE PATIENT EXPERIENCED A MASSIVE BLEED; THE PATIENT'S CONDITION WAS NOTED AS "EXTREMELY ILL". ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE ISSUE INVOLVED 1 OF 3 APPLIERS; IT WAS UNCLEAR AS TO WHICH INSTRUMENT MALFUNCTIONED.