AIR HOSE 5.0M SCHRADER/AESCULAP SMALL
Received May 7, 2019 · Event occurred Apr 5, 2019
Report 9610612-2019-00305 · MDR key 8588529
Device
Generic name
Highspeed Power Systems
Manufacturer
Aesculap AgModel number
GA506RCatalog number
GA506R
Lot number
52079373
Product problems
- Burst Container or Vessel
- Unintended Ejection
- Mechanical Problem
- Burst Container or Vessel
- Unintended Ejection
- Mechanical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
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. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE OUTER TUBE BURST INTRAOPERATIVELY. DURING A SURGICAL PROCEDURE IT WAS REPORTED THAT THE OUTER TUBE OF THE AIR HOSE BURST . NO STAFF OR PATIENT HARM. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ASSOCIATED MEDWATCH: 9610612-2019-00306.
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. INVESTIGATION: THE INVESTIGATION HAS BEEN CARRIED OUT BY THE AESCULAP TECHNICAL SERVICE (ATS). THE AIR HOSE WAS MANUFACTURED AND DISTRIBUTED IN NOVEMBER 2014. THE CURRENT MAINTENANCE DUE DATE ON THE AIR HOSE SHOWS "2018-04". THERE ARE NO INFORMATION IN THE SYSTEM REGARDING REPAIR/ MAINTENANCE IN THE PAST. A LABELING "ATS1712JP" ON THE AIR HOSE INDICATES THAT A REPAIR/MAINTENANCE TOOK PLACE AT THE ATS IN JAPAN IN DECEMBER 2017. THEREFORE, A MAINTENANCE WOULD HAVE BEEN NECESSARY IN DECEMBER 2018. THE OUTER AIR HOSE AS WELL AS THE INNER AIR HOSE HAVE BUSTED. NO DAMAGES CAN BE FOUND AT THE REMAINING FRAGMENTS OF THE HOSE, WHICH INDICATE WHY IT CAME TO THE BURST. THE MAINTENANCE DATE HAS EXPIRED THEREFORE WE ASSUME THAT THE ROOT CAUSE CAN BE TRACED BACK TO WEAR AND TEAR. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE 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 PROBABLY WEAR AND TEAR/MAINTENANCE RELATED. NO CAPA NECESSARY. ASSOCIATED MEDWATCH: 9610612-2019-00306.