NSK

Description of Event or Problem

ON MAY 29, 2026, NAKANISHI RECEIVED AN EMAIL FROM A DISTRIBUTOR (B)(4) STATING THAT THE DISTRIBUTOR HAD BEEN NOTIFIED BY THE NORWEGIAN MEDICAL PRODUCTS AGENCY (NOMA) IN NORWAY REGARDING AN INCIDENT REPORT SUBMITTED BY A USER ABOUT AN NSK SURGICAL DEVICE OVERHEATING AND CAUSING A BURN INJURY. THE DETAILS NAKANISHI OBTAINED ARE AS FOLLOWS: - THE EVENT OCCURRED ON (B)(6) 2026. - A DOCTOR WAS PERFORMING A SURGICAL PROCEDURE ON A PATIENT USING THE PRIMADO HIGH-SPEED DRILL (SERIAL NO. UNKNOWN). - DURING THE PROCEDURE, THE DEVICE BECAME ABNORMALLY HOT, EVEN WITH ADEQUATE WATER COOLING, AND CAUSED BURN MARKS ON THE SURFACE OF THE BRAIN IN ONE PATIENT AND A SECOND-DEGREE BURN IN ANOTHER.

Additional Manufacturer Narrative

ON JUNE 4, 2026, NAKANISHI RECEIVED AN EMAIL FROM THE DISTRIBUTOR (B)(4) REPORTING THAT THEY HAD VISITED THE HOSPITAL WHERE THE ADVERSE EVENT OCCURRED. DURING THE VISIT, THEY OBTAINED INFORMATION ABOUT OTHER ADVERSE EVENTS; HOWEVER, THEY WERE UNABLE TO OBTAIN DETAILS REGARDING THE INCIDENT THAT OCCURRED ON (B)(6) 2026, INCLUDING PATIENT INFORMATION. IN ADDITION, THE HOSPITAL WAS UNABLE TO IDENTIFY THE DEVICE INVOLVED IN THE ADVERSE EVENT, AND THEREFORE DEVICE COULD NOT BE RETURNED TO THE DISTRIBUTOR. AS A RESULT, FURTHER INSPECTION OF THE DEVICE FOR CAUSE BY NAKANISHI IS NO LONGER POSSIBLE.