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Patient 1
PRIOR TO THE REPAIR OF THE PRODUCT AN ANALYSIS HAS BEEN PERFORMED. THE INSTRUMENT WAS IN GOOD CONDITION FROM THE OUTSIDE. ALREADY A SHORT TEST RUN HOWEVER SHOWED, THAT THE PRODUCT RAN OUTSIDE OF THE SPECIFICATIONS: LOUD, ROUGH RUNNING NOISE, PLAY IN THE GUIDE BUSH AND AFTER A SHORT TEST RUN (WITHOUT LOAD!) THE HEAT UP WAS ALREADY REPRODUCIBLE. THE CURRENT CONSUMPTION WAS @ 500MA (VS.150MA). AFTER DISASSEMBLING OF THE PRODUCT HEAVY BLACK RESIDUE GOT VISIBLE INSIDE THE HEAD WHICH INDICATES THAT THE REPROCESSING AND CARE IS NOT PERFORMED AS REQUESTED BY IFU. THE BALL BEARINGS IN THE HEAD HAVE BEEN COMPLETELY WORN OUT AND FELL PARTIALLY APART. IN ADDITION, THE BALL BEARINGS OF THE INTERMEDIATE DRIVE AND THE INTERMEDIATE PIECE RAN ROUGH AND HAVE BEEN WORN OUT. FROM TECHNICAL ASPECT THE ROOT CAUSE FOR THE HEATING WAS THEREFORE THE STRONG RESIDUE IN THE INSTRUMENT WHICH LED TO INCREASED FRICTION AND THUS HEATING AND ALSO STRONGER WEAR AND TEAR SITUATION. THE WORN BALL BEARINGS ALSO CAUSED HIGHER RESISTANCE AND HENCE RISE IN TEMPERATURE. THE INJURY SHOWS THAT THE INSTRUMENT HAS BEEN USED TO KEEP THE TONGUE AWAY FROM TREATMENT AREA. IT IS LIKELY THAT THIS ALSO CAUSED AN INCREASE OF THE TEMPERATURE AS THE PUSH BUTTON COULD BE PRESSED WHILE THE INNER PARTS ARE ROTATING. THIS CAUSES ALSO HIGH FRICTION AND A QUICK HEAT UP. TO AVOID SUCH ISSUES THE USER INSTRUCTION CONTAINS ALREADY SEVERAL NOTES, WARNINGS AND REQUESTS HOW TO PREPARE THE HANDPIECE FOR EACH TREATMENT AND HOW TO USE IT: WARNING: HAZARDS FOR THE CARE PROVIDER AND THE PATIENT. IN THE CASE OF DAMAGE, IRREGULAR RUNNING NOISE, EXCESSIVE VIBRATION, UNTYPICAL WARMING OR WHEN THE CUTTER OR GRINDER CANNOT BE HELD. DO NOT USE FURTHER AND NOTIFY SERVICE. CAUTION: BURNING HAZARD FROM HOT INSTRUMENT HEAD OR HOT INSTRUMENTS COVER. IF THE INSTRUMENT OVERHEATS, BURNS MAY ARISE IN THE ORAL AREA. NEVER CONTACT SOFT TISSUE WITH THE INSTRUMENT HEAD OR INSTRUMENT COVER. THE FOLLOWING GUIDELINES MUST BE OBSERVED TO ENSURE SAVE USE OF THE ELECTRICALLY DRIVEN CONTRA-ANGLE HANDPIECES: THE SERVICE INSTRUCTIONS FOR CONTRA-ANGLE HANDPIECES MUST BE PRECISELY FOLLOWING WHEN USING KAVO SPRAY OR QUATTROCARE CARE SYSTEMS. BEFORE EACH USE, THE CONTRA-ANGLE HANDPIECE MUST BE CHECKED FOR EXTERNAL DAMAGE. BEFORE EACH USE, PERFORM A TEST RUN WITH THE CONTRA-ANGLE HANDPIECE, AND WATCH FOR ATYPICAL HEATING AND UNUSUAL NOISE AND VIBRATION. IMMEDIATELY STOP USING CONTRA-ANGLE HANDPIECES THAT ACT UNUSUAL. NEVER PRESS THE PUSH BUTTON DURING OPERATION. THIS ALSO INCLUDES LIFTING THE CHEEK OR TONGUE! TO ENSURE PROPER FUNCTION, THE MEDICAL DEVICE MUST BE SET UP ACCORDING TO THE REPROCESSING METHODS DESCRIBED IN THE KAVO INSTRUCTIONS FOR USE, AND THE CARE PRODUCTS AND CARE SYSTEMS DESCRIBED THEREIN MUST BE USED. KAVO RECOMMENDS SPECIFYING A SERVICE INTERVAL AT THE DENTAL OFFICE FOR A LICENSED SHOP TO CLEAN, SERVICE AND CHECK THE FUNCTIONING OF THE MEDICAL DEVICE. THIS SERVICE INTERVAL DEPENDS ON THE FREQUENCY OF USE AND SHOULD BE ADJUSTED ACCORDINGLY. ISSUE REPORTED AS SIMILAR PRODUCTS ARE SOLD TO THE US.