AIR HOSE 5.0M SCHRADER/AESCULAP SMALL
Received May 7, 2018 · Event occurred Apr 10, 2018
Report 9610612-2018-00194 · MDR key 7492175
Device
Generic name
High Speed Power Systems
Manufacturer
Aesculap AgModel number
GA506RCatalog number
GA506R
Lot number
51642053
Product problems
- Burst Container or Vessel
- Material Integrity Problem
- Burst Container or Vessel
- Material Integrity Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
(B)(6). DURING PROCEDURE, OUTER TUBE BURST. A SURGEON GOT HIT AROUND EYE BY A FRAGMENT. SOME FRAGMENTS WERE MISSING. NO INJURY FOR PATIENT AND THE SURGEON WAS REPORTED.
Additional Manufacturer Narrative
INVESTIGATION: THE INVESTIGATION HAS BEEN CARRIED OUT BY THE AESCULAP TECHNICAL SERVICE DEPARTMENT (ATS). THE GA506R HAS BEEN MANUFACTURED IN 2010. THE LAST REPAIR WAS EXECUTED AT ATS (B)(6) IN MARCH 2017. IT IS NOT POSSIBLE TO DETERMINE WHAT WAS DONE DURING THE REPAIR. OPTICALLY, THE TUBE IS IN A USED CONDITION. THE SURFACE OF THE TUBE SHOWS SCATTERED MECHANICAL DAMAGES AND BRUISES. THE O-RING IS MISSING A THE MOTOR COUPLING. A FUNCTIONAL TEST WAS NOT POSSIBLE, DUE TO THE FACT THAT THE OUTER TUBE BURST AND THE INNER TUBE IS NOT CONNECTED ANYMORE WITH THE CONNECTOR NIPPLE. THE ROOT CAUSE IS MOST PROBABLY ATTRIBUTABLE TO WEAR AND TEAR AS WELL AS HANDLING. A MAINTENANCE MUST TAKE PLACE AT LEAST ONCE A YEAR. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR THE ABOVE MENTIONED LOT NUMBER 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 HANDLING/ WEAR AND TEAR RELATED. NO CAPA IS NECESSARY.