DS HEADNECK 3.0T

Additional Manufacturer Narrative

THE COMPLAINT OF A MIRROR FALLING ON A PATIENTS HEAD WAS REPORTED TO INVIVO 11/12/2019. REQUEST WENT OUT TO THE SITES LOCAL FIELD SERVICE ENGINEER ON 11/20/2019 TO HAVE THE PART WHICH HAD FAILED TO BE RETURNED. THE PART WAS RETURNED TO INVIVO PRIOR TO 12/09/2020. WHEN THE FAILED ASSEMBLY WAS RECEIVED IT WAS INSPECTED BY THE ENGINEERING TEAM. VISUAL INSPECTION SHOWS THERE HAVE BEEN MADE AT LEAST 3 ATTEMPTS TO REPAIR THIS PART IN THE FIELD. (HOT GLUE, DOUBLE SIDED TAPE & TAPE WRAPPED AROUND THE WHOLE ASSEMBLY). FURTHER INVESTIGATION SHOWS THAT THE PROTECTIVE POLY FILM ON THE BACKSIDE OF THE REFLECTIVE MIRROR WAS STILL ATTACHED. THIS FILM WOULD DECREASE THE EFFECTIVENESS OF THE ADHESIVE FIXING THE MIRROR TO THE HOUSING. REVIEW OF THE DRAWINGS INDICATES SOME AMBIGUITY ON THE DRAWING. ECR-073261 WAS CREATED TO ENSURE THAT THE SUPPLIER (SEAWAY PLASTICS) ASSEMBLES THE MIRRORS CORRECTLY. ENGINEERING QUARANTINED THE 80 MIRROR ASSEMBLIES REMAINING IN STOCK. THERE WERE 5 DIFFERENT LOTS WHICH ALL HAD A QTY OF 16. A RANDOM SAMPLING FROM EACH LOT (4 EACH) INDICATES THERE WERE NO ADDITIONAL ASSEMBLIES IN STOCK WITH THIS ISSUE. SCAR #41306 WAS CREATE TO INFORM THE SUPPLIER. THE ROOT CAUSE OF THE COMPLAINT AS DESCRIBED ABOVE IS A TRIBUTE TO AN ASSEMBLY ERROR MADE BY THE SUPPLIER (SEAWAY PLASTICS) REVIEW OF HHE 1105-2020 INDICATES THAT THIS FAILURE IS ACCEPTABLE WITH A SEVERITY OF A 3 AND A PROBABILITY OF A 1. IT IS RECOMMENDED THAT NO FURTHER ACTION IS REQUIRED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Additional Manufacturer Narrative

SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL ONGOING FOR THIS EVENT. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

Description of Event or Problem

WHILE THE CUSTOMER WAS ATTACHING THE MIRROR ASSEMBLY TO THE COIL, THE MIRROR HAD FALLEN OUT THE ASSEMBLY AND HIT THE PATIENT¿S HEAD. THE FSE REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.