ITERO ELEMENT 2

Additional Manufacturer Narrative

A THOROUGH INVESTIGATION WAS PERFORMED TO ASSESS THIS EVENT. A CROSS FUNCTIONAL TEAM ANALYZED THE INVESTIGATIONAL FINDINGS AND DETERMINED THE SEVERITY OF THE REPORTED DEFICIENCY, EVALUATED THE HAZARD, AND CONSIDERED THE POTENTIAL RISK TO PATIENTS AND USERS. IT WAS CONCLUDED THAT NO FURTHER ACTIONS ARE REQUIRED TO PREVENT THE RE-OCCURRENCE OF THE HARM. THE COMPANY DID DECIDE TO INCREASE THE ROBUSTNESS OF THE CABLES TO MEET THE OBSERVED USE CONDITIONS, AS A RESULT OF THIS INVESTIGATION. NO CLEAR TREND IS IDENTIFIED, BUT WE CONTINUE MONITORING TO MAKE SURE THERE IS NO CHANGE TO THE TREND OR ANY CHANGE THAT COULD AFFECT THIS DECISION. ADDITIIONAL DATA: H6 INVESTIGATION FINDINGS UPDATED WITH CODE 122 AFTER INVESTIGATION COMPLETED. H6 INVESTIGATION CONCLUSIONS UPDATED WITH CODE 4319 AFTER INVESTIGATION COMPLETED.

Description of Event or Problem

THE TREATING DOCTOR REPORTED THE EVENT: WHILE TRYING TO PLUG IN THE POWER CABLE THE USER SENSED A MINOR ELECTRICAL DISCHARGE AND A SPARK FROM THE CABLE WHICH CAUSED A MINOR SKIN BURN. IT HAPPENED AS SHE APPLIED HIGHER FORCE THAN USUAL TO PLUG IT IN. SHE WENT TO GET CHECKED OUT IN THE HOSPITAL BUT WAS NOT HOSPITALIZED. IT IS UNKNOWN IF ANY MEDICATIONS WERE PRESCRIBED TO ALLEVIATE THE REPORTED MINOR INJURY (BURN). THE STAFF MEMBER IS DOING FINE. THERE WAS NO SMOKE PRESENT. THERE WERE NO POWER OUTAGES REPORTED. IT IS UNKNOWN IF A CIRCUIT BREAKER WAS PRESENT.

Additional Manufacturer Narrative

THE CURRENT USER MANUAL CONTAINS THE FOLLOWING WARNINGS: "DO NOT CONNECT THE SCANNER TO A MAINS SUPPLY WITHOUT PROTECTIVE GROUNDING, IN ORDER TO AVOID THE RISK OF ELECTRICAL SHOCK", "DO NOT USE THE EQUIPMENT IF A SCANNER MALFUNCTION OCCURS OR IF PHYSICAL DAMAGE IS OBSERVED, IN ORDER TO AVOID ELECTRICAL SHOCK OR PHYSICAL INJURY. CALL CUSTOMER SUPPORT", AND "AVOID TWISTING, KNOTTING, PULLING, AND STEPPING ON THE WAND CABLE AND THE POWER CABLE". AN INVESTIGATION INTO THE ROOT CAUSE OF THE EVENT IS BEING CONDUCTED. BACK IN JAN-2023, AN INVESTIGATION WAS PERFORMED ON THE POWER CABLE DAMAGE ISSUE (WITH NO INJURY) AND CONCLUDED THAT POWER CABLE DAMAGE CAN GET DAMAGED DUE TO THE INCAUTIOUS USE. IN ADDITION, A PREVIOUS EVENT LED TO THE INVESTIGATION OF AN ADDITIONAL DEFECTIVE CABLE AND A CORRECTIVE ACTION IS ALREADY IN PLACE TO INVESTIGATE AND CORRECT THIS ISSUE. THIS EVENT IS BEING REPORTED AS AN MDR DUE TO MINOR INJURY (BURN) DUE TO MALFUNCTION OF MEDICAL DEVICE.

Description of Event or Problem

THE TREATING DOCTOR REPORTED THE EVENT: WHILE TRYING TO PLUG IN THE POWER CABLE THE USER SENSED A MINOR ELECTRICAL DISCHARGE AND A SPARK FROM THE CABLE WHICH CAUSED A MINOR SKIN BURN. IT HAPPENED AS SHE APPLIED HIGHER FORCE THAN USUAL TO PLUG IT IN. SHE WENT TO GET CHECKED OUT IN THE HOSPITAL BUT WAS NOT HOSPITALIZED. IT IS UNKNOWN IF ANY MEDICATIONS WERE PRESCRIBED TO ALLEVIATE THE REPORTED MINOR INJURY (BURN). THE STAFF MEMBER IS DOING FINE. THERE WAS NO SMOKE PRESENT. THERE WERE NO POWER OUTAGES REPORTED. IT IS UNKNOWN IF A CIRCUIT BREAKER WAS PRESENT. IMAGE ATTACHED FOR MINOR INJURY (BURN).

Additional Manufacturer Narrative

UPDATES WERE MADE AFTER REVIEWING THE QUALITY OF DEVICE IDENTIFICATION INFORMATION SUBMITTED PREVIOUSLY AGAINST DATA IN THE GUDID.