AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL
Received May 18, 2017
Report 9610612-2017-00256 · MDR key 6575960
Device
Generic name
High Speed Power Systems
Manufacturer
Aesculap AgModel number
GA513RCatalog number
GA513R
Lot number
51760202
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY THE AESCULAP TECHNICAL SERVICE DEPARTMENT. THE LAST MAINTENANCE TOOK PLACE IN NOVEMBER 2016. NO PRODUCT FAILURE COULD BE DETECTED. A FUNCTIONAL TESTING WAS NOT POSSIBLE. ITS NOT POSSIBLE TO RECONSTRUCT THE FRACTURE AREA DUE TO THE FACT THAT SEVERAL HOSE FRAGMENTS ARE MISSING. OPTICALLY, THE HOSE DOES NOT SHOW SIGNIFICANT SIGNS OF USAGE. JUST A FEW AGE-RELATED IMPURITIES. BATCH HISTORY REVIEW: THE DEVICE QUALITY MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. RATIONAL: MOST LIKELY THE BURST OF THE OUTER HOSE WAS CAUSED BY MECHANICAL DAMAGE FROM THE OUTSIDE, A BRUISE, FOR EXAMPLE. CORRECTIVE ACTION: NO CAPA IS NECESSARY.
Additional Manufacturer Narrative
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 THE TUBE BURST AT THE BEGINNING OF THE SURGERY. FRAGMENTS OF THE HOSE BURST ALL THROUGHOUT THE SURGICAL ROOM AND ALL THE FRAGMENTS COULD NOT BE FOUND.