ACCULAN II PISTOL-SHAPED BATTERY DRILL

Additional Manufacturer Narrative

INVESTIGATION: THE INVESTIGATION HAS BEEN CARRIED OUT BY THE ATS DEPARTMENT. THE COMPLAINED FAILURE ("MACHINE DID NOT STOP") CAN NOT BE REPORDUCED DURING THE FUNCTIONAL TESTING. ITS NOT POSSIBLE TO START THE DEVICE BY PRESSING THE SWITCH BUTTONS. ONLY AFTER A MANUAL TURING OF THE DRIVE SPINDLE, THE DEVICE STARTS TO WORK. AFTER RELEASING THE SWITCH BUTTONS, THE MACHINE STOPS IMMEDIATELY. THE SWITCH BUTTONS ARE MOVING ROUGHLY. THE INTERIOR IS SOILED AND WET. ABRASION OF COALDUST CAN BE FOUND. THE SWITCH BUTTONS ARE CLEAN BUT DRY (NO GREASE). CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. RATIONAL: THE WETNESS INSIDE THE MACHINE INDICATES, THAT AN INSUFFICIENT CLEANING PROCESS MAY HAVE LED TO THE DEFECT. ITS POSSIBLE THAT THE GREASE AT THE SWITCH BUTTONS HAS BEEN WASHED AWAY DURING THE CLEANING PROCESS. THIS COULD HAVE LED TO THE DESCRIBED FAILURE. CORRECTIVE ACTION: NO CAPA IS NECESSARY.

Additional Manufacturer Narrative

REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

Description of Event or Problem

COUNTRY OF COMPLAINT: GERMANY. IT WAS REPORTED THAT DURING SURGERY THE DRILL CONTINUED TO RUN AND WOULD NOT STOP AND THE SURGICAL NURSE DRILLED INTO THEIR FINGERS.