Description of Event or Problem · 1
(B)(6), A DENTAL ASSISTANT AT (B)(6), CONTACTED NSK AMERICA (HEREIN AFTER NAM) CUSTOMER SERVICE REP 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 EXCHANGED 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 REP COMPLETED PRODUCT COMPLAINT FORM (B)(4) AND FORWARDED IT TO QUALITY ASSURANCE (QA). COMPLAINANT WAS CONTACTED BY NSK AMERICA QA MANAGER AT 11:45AM ON (B)(4) 2014 FOR ADD'L INFO 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 INFO WAS GATHERED: HANDPIECE HAD BEEN PREVIOUSLY REPAIRED BY SEVERAL 3RD PARTY REPAIR SHOPS, SPECIFICALLY MENTIONED WERE (B)(6) REPAIR IN (B)(4) WHO CLAIMED TO USE ONLY GENUINE NSK PARTS AND HAYES HANDPIECE REPAIR. THE HANDPIECE HAS BURNED AT LEAST TWO PTS. THE COLLECTION OF ADD'L INFO WAS DISCUSSED AND IT WAS DECIDED THAT A REQUEST FOR ADD'L INFO WOULD BE FAXED TO (B)(6) FROM NAM TO FILL OUT AND RETURN. NAM QA MANAGER ISSUED A (B)(4) CALL TAG TO HAVE THE HANDPIECE SHIPPED TO NAM AND FAXED THE FORM LETTER TO (B)(6) ON (B)(4) 2014. BOTH THE HANDPIECE AND COMPLETED ADD'L INFO REQUEST WERE RECEIVED BY NAM ON (B)(4) 2014. THE HANDPIECE WAS AUTOCLAVED UPON RECEIPT BY NAM, PHOTOGRAPHED AND FORWARDED TO (B)(4) 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) USA. A REPLACEMENT HANDPIECE WAS PROVIDED TO (B)(6) AT NO CHARGER PER STANDARD OPERATING PROCEDURES. THE ADD'L INFO REQUEST CONTAINED THE FOLLOWING NARRATIVE: THE PROCEDURE BEING PERFORMED AT THE TIME OF THE EVENT WAS #30 AND #31 OCCLUSAL AND BUCCAL FILLINGS. PT HAD RECEIVED 1 CARPULE OF LIDOCAINE ON THE LOWER RIGHT ANESTHETIC BLOCK AND 1/2 CARPULE ARTICAINE INFILTRATION AT #39 AND #31. NO ABNORMALITY OR MALFUNCTION WAS OBSERVED PRIOR TO THE INJURY. FIRST INDICATION OF AN INJURY NOTICED WAS A WHITE PLACE ON THE PT'S CHEEK AT #31 AND HANDPIECE WAS HOT. NARRATIVE OF EXTENT OF INJURY: PT WAS BURNT DURING A PROCEDURE FOR FILLINGS, ON HER CHEEK BEHIND #31. THE BURN WAS ABOUT THE SIZE OF THE HANDPIECE HEAD, AND LEFT CHEEK TISSUE SLIGHTLY WHITE. INFORMED PT OF THE BURN, AS WELL AS SHOWED HER IN A MIRROR. NARRATIVE OF INTERVENTION REQUIRED: NA. NARRATIVE OF TREATMENT ADMINISTERED: NONE; FORTUNATELY THE BURN WAS A TERRIBLE BURN; INFORMED THE PATIENT TO RINSE WITH WARM SALT WATER AND TO CALL IF PATIENT NEEDED DR. (B)(6) TO RECHECK FOR ANY REASON; PATIENT DID NOT CALL FOR ANY RECHECKS OR COMPLAINTS OF IRRITATION FROM THE BURN." NO FOLLOW UPS WERE CONDUCTED. HANDPIECE WAS SENT TO (B)(4) FOLLOWING THE EVENT WHERE IT RECEIVED COMPLETE (B)(6); [ILLEGIBLE] WATER SPRAY WAS USED IN BOTH CASES." THE ADDITIONAL INFORMATION RESPONSE WAS SIGNED BY (B)(6), DDS. 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) USA ON 11/04/2009. (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). IMPORTER OF THIS PARTICULAR DEVICE, WAS AUTHORIZED BY NHQ TO PERFORM REPAIRS TO (B)(4) PRODUCTS IMPORTED AND SOLD BY (B)(4) USA AND PURCHASED REPAIR PARTS DIRECTLY FROM NHQ. NAM QA MANAGER SENT REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE ABOVE LISTED SERVICE (B)(4) 2014. RESPONSE FROM (B)(4) USA PRODUCT MANAGER WAS RECEIVED ON 8/15/2014. HANDPIECE WAS SOLD BY (B)(4) USA 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 MFG. 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 8/14/2014 AND BY US MAIL ON 8/18/2014. AS OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED FROM (B)(4). NAM QA MANAGER SENT REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE ABOVE LISTED SERVICE RECORDS TO (B)(4) BY EMAIL ON 8/14/2014 AND BY US MAIL ON 8/18/2014. AS OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED FROM (B)(4). ON (B)(6) 2014 (B)(6) AGAIN CONTACTED NSK AMERICA WITH ADDITIONAL QUESTIONS REGARDING PRODUCT REPAIR. MIRANDA 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 STAR BRAND ELECTRIC DENTAL HANDPIECE AND THAT THEY WERE IDENTICAL TO THE GENUINE NSK PARTS. NSK AMERICA IS AWARE THAT (B)(4) MANUFACTURES HANDPIECES FOR STAR BUT DOES NOT PUBLICIZE THIS INFORMATION NOR MAKE ANY CLAIMS TO THE COMPATIBILITY OF PARTS BETWEEN PRIVATE LABEL AND NSK BRAND PRODUCTS.