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

Additional Manufacturer Narrative

MANUFACTURING 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 LIKELIHOOD 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.

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.