SE 3.0M AESC.-DRAEGER/AESC.SMALL

Additional Manufacturer Narrative

B5: CLARIFICATION.

Description of Event or Problem

CLARIFICATION OF USER TINNITUS: ACCORDING TO THE REPORTER, THE USER JUST MENTIONED AT THE SUDDEN BURST OF THE HOSE HE HAD (RINGING IN HIS EARS) TINNITUS, BUT HE IS FINE. NO HARM OR INJURY.

Additional Manufacturer Narrative

INVESTIGATION THE INVESTIGATION WAS CARRIED OUT BY AESCULAP TECHNICAL SERVICE (ATS). THE COMPLAINED GA513R WAS DELIVERED IN NOVEMBER 2016. A REPAIR OR MAINTENANCE CANNOT BE FOUND IN OUR DATABASE. OPTICALLY, THE PRODUCT IS IN A USED CONDITION. THE AIR HOSE BUSTED AT THE HAND PIECE SIDE. A RECONSTRUCTION OF THE BUSTED AREA IS NOT POSSIBLE ANYMORE DUE TO MISSING FRAGMENTS. FURTHERMORE, DAMAGES (CHAFE MARKS) AND STAINING OF ERRATIC APPEARANCE COULD BE FOUND. ADDITIONALLY THE MAINTENANCE DUE DATE IS EXCEEDED. A MAINTENANCE SHOULD HAVE TOOK PLACE IN FEBRUARY 2018. BATCH HISTORY REVIEW THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR THE MENTIONED LOT NUMBER (52281760) AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. NO FURTHER COMPLAINTS REGISTERED AGAINST THE SAME LOT NUMBER. CONCLUSION AND ROOT CAUSE THE FAILURE IS MOST PROBABLY USAGE/WEAR AND TEAR RELATED. RATIONALE ON THE BASIS OF THE INVESTIGATION RESULTS, IT IS MOST LIKELY THAT A USAGE RELATED FAILURE (DAMAGING OF THE AIR HOST) IN COMBINATION WITH WEAR AND TEAR (EXCEEDED MAINTENANCE DATE) LED TO THE BURST OF THE AIR HOSE. A MAINTENANCE DID NOT TAKE PLACE SINCE THE AIR HOST WAS DISTRIBUTED. ACCORDING TO THE IFU, A MAINTENANCE MUST BE EXECUTED AT LEAST ONCE A YEAR.

Additional Manufacturer Narrative

WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THE HOSE RUPTURED INTRAOPERATIVELY. THE REPORTER INDICATED THAT THE DURING A CRANIOTOMY/SKULL RECONSTRUCTION SURGICAL PROCEDURE ON (B)(6) 2019 AT 08:30 IN THE MORNING, THE HOSE SHOWED NO SIGN OF PROBLEMS DURING THE OPERATION. WHEN THE SURGEON WAS USING THE HOSE (GA513R/SN4524) WITH THE HAND PIECE/CUTTER BURR AN HOUR LATER, THERE WAS A STRONG SOUND AND VIBRATION. THE TUBE RUPTURED, THE PATIENT WAS NOT AFFECTED, BUT THE USER HAD TINNITUS. THE ENTIRE SYSTEM WAS REPLACED AND THE OPERATION WAS COMPLETE SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE USER'S OUTCOME.