KANGAROO

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THE ITEM IS NOT WORKING AND HAS HOLES.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. HOWEVER, PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. A GEMBA ON-SITE INSPECTION OF THE MANUFACTURING PROCESS WAS CARRIED OUT. ALL PROCESSES WERE REVIEWED AND THEIR CORRECT OPERATION WAS VERIFIED. NO ABNORMAL CONDITIONS WERE FOUND THAT COULD CONTINUE TO TRIGGER THE REPORTED CONDITION. BASED ON ALL AVAILABLE INFORMATION AND GIVEN THAT NO SAMPLES OR IMAGES WERE AVAILABLE FOR TECHNICAL EVALUATION, A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.