RELIANCE

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN, THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS OPENING THEIR 6500 SERIES RELIANCE ENDOSCOPE DRYING AND STORAGE CABINET, A SCOPE HOLDER COMPONENT DETACHED AND FELL TO THE BASE OF THE CABINET. WHILE BENDING TO RETRIEVE THE FALLEN COMPONENT, AN ENDOSCOPE ULTRASOUND ADAPTOR WITH ITS HOLDER FELL FROM THE CABINET AND CONTACTED THE EMPLOYEE'S HEAD RESULTING IN AN INJURY. MEDICAL TREATMENT WAS SOUGHT; IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.