FDA Adverse Event
Summary report: N
REMANUFACTURED RENAISSANCE STERILIZER
MDR report key: 4081415
·
Received September 11, 2014
Report
- Report Number
- 3005899764-2014-00086
- Date Received
- September 11, 2014
- Date of Event
- August 13, 2014
- Report Date
- September 11, 2014
- Manufacturer
- STERIS MEXICO, S. DE R.L. DE C.V.
- Product Code
- FLE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER AND FOUND A PIN SIZE HOLE IN THE TRAP COOL DOWN WATER LINE. THE TECHNICIAN REPLACED THE WATER LINE AND CONFIRMED THE STERILIZER TO BE OPERATIONAL. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR STERILIZER. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560981 | REMANUFACTURED RENAISSANCE STERILIZER | STERILIZER | FLE | STERIS MEXICO, S. DE R.L. DE C.V. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |