Description of Event or Problem · 1
(B)(6) CONTACTED NSK AMERICA, A CORPORATE AFFILIATE (HEREIN AFTER NAM) CUSTOMER SERVICE REPRESENTATIVE BY TELEPHONE ON (B)(6) 2014 REGARDING A MALFUNCTIONING HANDPIECE. (B)(6) STATED THAT THE HANDPIECE WAS PROBLEMATIC, HAD BEEN REPAIRED MULTIPLE TIMES AND WAS HOPING TO EXCHANGE IT FOR A NEW ONE AT A REDUCED COST. UPON REVIEW OF RECORDS BY NAM CUSTOMER SERVICE NO RECORD OF SALE OR PAST REPAIRS PERFORMED BY NAM WERE FOUND. UPON INFORMING (B)(6) OF THIS SHE STATED THAT THE HANDPIECE HAD INJURED A PT. THE NAM CUSTOMER SERVICE REPRESENTATIVE COMPLETED PRODUCT COMPLAINT FORM (B)(4) AND FORWARDED IT TO QUALITY ASSURANCE (QA). COMPLAINANT WAS CALLED BY NSK AMERICA QA MANAGER AT 11:45AM ON (B)(6) 2014 FOR ADDITIONAL INFORMATION AND A MESSAGE WAS LEFT WITH RECEPTION TO RETURN THE CALL. (B)(6) CALLED BACK AT 1:40PM THE SAME DAY. DURING THE PHONE CALL, THE FOLLOWING INFORMATION WAS GATHERED: HANDPIECE HAD BEEN PREVIOUSLY REPAIRED BY SEVERAL THIRD PARTY REPAIRS SHOPS, SPECIFICALLY MENTIONED WERE (B)(4) WHO CLAIMED TO USE ONLY GENUINE NSK PARTS AND (B)(4). THE HANDPIECE HAS BURNED AT LEAST TWO PTS. THE COLLECTION OF ADDITIONAL INFORMATION WAS DISCUSSED AND IT WAS DECIDED THAT A REQUEST FOR ADDITIONAL INFORMATION WOULD BE FAXED TO (B)(6) FROM NAM TO FILL OUT AND RETURN. NAM QA MANAGER ISSUED A FEDERAL EXPRESS CALL TAG TO HAVE THE HANDPIECE SHIPPED TO NAM AND FAXED THE FORM LETTER TO (B)(6) ON (B)(6) 2014. BOTH THE HANDPIECE AND COMPLETED ADDITIONAL INFORMATION REQUEST WERE RECEIVED BY NAM ON (B)(6) 2014. THE HANDPIECE WAS AUTOCLAVED UPON RECEIPT BY NAM, PHOTOGRAPHED AND FORWARDED TO NAKANISHI INC (NHQ) FOR FURTHER INVESTIGATION ON 08/15/2014. LABELING ON THE HANDPIECE INDICATES THAT IT WAS MANUFACTURED FOR IMPORT TO THE UNITED STATES BY (B)(4). A REPLACEMENT HANDPIECE WAS PROVIDED TO (B)(6) AT NO CHARGE PER NAM STANDARD OPERATING PROCEDURES. THE ADDITIONAL INFORMATION REQUEST CONTAINED THE FOLLOWING NARRATIVE: THE PROCEDURE BEING PERFORMED AT THE TIME OF THE EVENT WAS A NUMBER 31 CROWN PREP. PT HAD RECEIVED 2 CAPSULES OF LIDOCAINE ON THE LOWER RIGHT ANESTHETIC BLOCK AND 1/2 CARPULE ARTICAINE INFILTRATION AT NUMBER 31. NO ABNORMALITY OR MALFUNCTION WAS OBSERVED PRIOR TO THE INJURY. FIRST INDICATION OF AN INJURY WAS WHEN THE (B)(6) NOTICED A WHITE PLACE ON THE PT'S CHEEK. DOCTOR FELT HEAD OF HANDPIECE AND IT WAS HOT TO TOUCH. NARRATIVE OF EXTENT OF INJURY: "HANDPIECE (C8Z02737) BRUNT INSIDE OF PT'S CHEEK NEXT TO NUMBER 31. THE BURN WAS THE SIZE OF A QUARTER AND VERY WHITE THE DAY OF THE INJURY ((B)(6) 2013); SPOKE TO PT ON (B)(6) 2013 BY PHONE. SHE WAS HAVING SWELLING IN CHEEK, 'LIKE I HAVE A JAW BREAKER IN MY CHEEK'. PAIN LEVEL OK; ON (B)(6) 2013 PT PRESENT IN OFFICE-PAINFUL, BUT SWELLING HAD WENT DOWN; ON (B)(6) 2013 CHEEK LOOKED GREAT AND ABLE TO SEAT NUMBER 31 CROWN." NARRATIVE OF INTERVENTION REQUIRED: "WE FOLLOWED UP CLOSELY WITH HER, AND SHE HEALED SLOWLY BUT ADEQUATELY, THE SITE LOOKED NORMAL AT HER LAST HYGIENE VISIT ((B)(6) 2014)." NARRATIVE OF TREATMENT ADMINISTERED: "NO TREATMENT NEEDED OTHER THAN: KEEP DR (B)(6) INFORMED; RECOMMENDED IBUPROFEN AROUND THE CLOCK, WARM SALT WATER RINSES, CAN ALSO RINSE WITH MILK OF MAGNESIA AND WATER, GAVE PRESCRIPTIONS FOR AMOXICILLIN 500MG AND ORAL BASE; DOCTOR ALSO SPOKE WITH PT ABOUT HAVING BURN EVALUATED BE ORAL SURGEON; PT SAID IF NEED BE BUT DIDN'T HAVE TO GO." FOLLOW UP COMPLETED AND INJURY HEALED NORMALLY WITHOUT COMPLICATIONS. NO FURTHER MEDICAL ATTENTION WILL BE REQUIRED. HANDPIECE WAS SENT TO (B)(4) FOLLOWING THE EVENT WHERE IT RECEIVED COMPLETE OVERHAUL. ADDITIONAL INFORMATION NARRATIVE: "THIS HANDPIECE IS ONE OFFICE WE HAVE. WE MAINTAIN THEM ALL IN THE SAME MANNER, BUT THIS IS THE ONLY ONE THAT HAS EXHIBITED RECURRENT DIFFICULTY." THE ADDITIONAL INFORMATION RESPONSE WAS SIGNED BY (B)(6). INCLUDED WITH THE RESPONSE WERE 5 INVOICES SHOWING THE HANDPIECE WAS SERVICED BY (B)(4) ON (B)(4) 2014, (B)(4) 2013, (B)(4) 2012. ONE INVOICE WAS PROVIDED SHOWING PRIOR SERVICE BY (B)(4) ON (B)(4) 2009. (B)(4) IS NOT AUTHORIZED NOR TRAINED BY NAM/NHQ TO REPAIR NSK PRODUCTS. REPAIR PARTS FOR THIS MODEL ARE NOT AVAILABLE FOR PURCHASE FROM NAM BY (B)(4). (B)(4), IMPORTER OF THIS PARTICULAR DEVICE, WAS AUTHORIZED BY NHQ TO PERFORM REPAIRS TO NAKANISHI PRODUCTS IMPORTED AND SOLD BY (B)(4) AND PURCHASED REPAIR PARTS DIRECTLY FROM NHQ. NAM QA MANAGER SENT REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE ABOVE LISTED SERVICE ALONG WITH ANY OTHER SERVICE RECORDS FOR THIS HANDPIECE TO (B)(4) BY EMAIL ON (B)(4) 2014. RESPONSE FROM (B)(4) PRODUCT MANAGER WAS RECEIVED ON (B)(4) 2014. HANDPIECE WAS SOLD BY (B)(4) ON (B)(4) 2008 HANDPIECE WAS SERVICED ON (B)(4) 2009. THE RECORD PROVIDED CONTAINED THE FOLLOWING NOTES. EVALUATION NOTES: "THE HP IS HEATING UP A LITTLE AND THE CARTRIDGE AND DRIVE SHAFT HAVE TO BE REPLACED: REPAIR NOTES: "REPAIRED AND TESTED TO MFR. SPECIFICATIONS". PARTS USED: 5015538U0 - C600C022A001 DRIVESHAFT X95L, 5015536U0, C600C015001 CARTRIDGE X95L. POST REPAIR INSPECTION TEST: CHUCK STRENGTH - PASSED, VIBRATION - PASSED, NOISE - PASSED. NAM QA MANAGER SENT REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE ABOVE LISTED SERVICE RECORDS TO (B)(4) BY EMAIL ON (B)(4) 2014 AND BY US MAIL ON (B)(4) 2014. AS OF THIS REPORT ((B)(6) 2013) NO RESPONSE HAS BEEN RECEIVED FROM (B)(4). ON (B)(6) 2014 (B)(6) AGAIN CONTACTED NSK AMERICA WITH ADDITIONAL QUESTIONS REGARDING PRODUCT REPAIR. (B)(6) HAD BEEN CONTACTED BY (B)(4) WHO INFORMED HER THAT IT WAS (B)(4) THAT HAD REPAIRED THE HANDPIECE, NOT NSK AS SHE HAD BEEN PREVIOUSLY INFORMED. (B)(4) INFORMED (B)(6) THAT HE USED PARTS FOR THE (B)(4) BRAND ELECTRIC DENTAL HANDPIECE AND THAT THEY WERE IDENTICAL TO THE GENUINE NSK PARTS. NSK AMERICA IS AWARE THAT NAKANISHI MANUFACTURES HANDPIECES FOR (B)(4), BUT DOES NOT PUBLICIZE THIS INFORMATION NOR MAKE ANY CLAIMS TO THE COMPATIBILITY OF PARTS BETWEEN PRIVATE LABEL AND NSK BRAND PRODUCTS.