AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL

Additional Manufacturer Narrative

AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. AGE OF DEVICE: 7 YEARS, 2 MONTHS. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PERFORATOR AND AIR HOSE. WHILE USING THE DEVICE SET AT 0.6 MPA AND DRILLING, A PART OF THE HAND PIECE WAS "BURST" AND DAMAGED. THE REPORTER DID NOT HAVE FURTHER SPECIFIC DETAILS BUT ASSUMED THAT ANOTHER INSTRUMENT WAS USED TO FINISH THE SURGERY. NO PATIENT INJURY NOR HARM TO MEDICAL STAFF WAS REPORTED. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

Additional Manufacturer Narrative

MANUFACTURING EVALUATION: INVESTIGATION - WE RECEIVED THE AIR HOSE FOR INVESTIGATION IN A DECONTAMINATED CONDITION. THE INVESTIGATION WAS CARRIED OUT BY THE AESCULAP TECHNICAL SERVICE (ATS). THE COMPLAINED PRODUCT WAS MANUFACTURED IN AUGUST 2012. A REPAIR OR MAINTENANCE CANNOT BE FOUND IN OUR DATABASE. A LABEL/STAMP WITH "ATS1704JPN" CAN BE FOUND ON THE PRODUCT WHICH INDICATES THAT A MAINTENANCE/REPAIR TOOK PLACE DIRECTLY IN JAPAN IN APRIL 2017. THEREFORE, THE NEXT MAINTENANCE WOULD HAVE BEEN NECESSARY IN APRIL 2018. OPTICALLY, THE PRODUCT IS IN A USED CONDITION. THE AIR HOSE BURST AT THE HAND PIECE SIDE. A RECONSTRUCTION OF THE BURST AREA IS NOT POSSIBLE ANYMORE DUE TO MISSING FRAGMENTS. FURTHERMORE, DAMAGES/CHAFE MARKS OF ERRATIC APPEARANCE COULD BE FOUND. BATCH HISTORY REVIEW - THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR THE MENTIONED LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE - THE FAILURE IS MOST LIKELY USAGE/WEAR AND TEAR RELATED. RATIONALE - ON THE BASIS OF THE INVESTIGATION RESULTS, IT IS MOST LIKELY THAT A USAGE RELATED FAILURE (DAMAGE OF THE AIR HOSE) IN COMBINATION WITH WEAR AND TEAR (EXCEEDED MAINTENANCE DATE) LED TO THE BURST. A MAINTENANCE DID NOT TAKE PLACE SINCE THE AIR HOSE WAS DISTRIBUTED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), A MAINTENANCE MUST BE EXECUTED AT LEAST ONCE A YEAR.