FDA Adverse Event
Summary report: N
RELIANCE ENDOSCOPE PROCESSING SYSTEM
MDR report key: 2032889
·
Received March 29, 2011
Report
- Report Number
- 9680353-2011-00007
- Date Received
- March 29, 2011
- Date of Event
- February 28, 2011
- Report Date
- March 29, 2011
- Manufacturer
- STERIS CANADA CORPORATION
- Product Code
- MEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A STERIS TECHNICIAN INSPECTED THE UNIT AND FOUND THE HOSE CLAMP ON THE PROCESSOR'S MAIN HOT WATER LINE HAD LOOSENED CAUSING THE HOSE TO COME OFF AND WATER TO LEAK; THE LOOSENING WAS CAUSED BY THE WATER PRESSURE IN THE HOSE. THE TECHNICIAN REPLACED THE HOSE CLAMP, RAN A TEST CYCLE AND PLACED THE UNIT BACK INTO SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THIS EQUIPMENT. STERIS WILL SUBMIT A FOLLOW UP REPORT SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THE RELIANCE ENDOSCOPE PROCESSOR LEAKED IN THE ROOM IN WHICH THE UNIT IS LOCATED. NO INJURIES WERE REPORTED TO PATIENTS OR HOSPITAL STAFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELIANCE ENDOSCOPE PROCESSING SYSTEM | WASHER/DISINFECTOR | MEC | STERIS CANADA CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |