FDA Adverse Event
Other
Summary report: N
EAGLE 3000 STAGE II STERILIZER
MDR report key: 1277465
·
Received November 7, 2008
Report
- Report Number
- 2515984-2008-00013
- Event Type
- Other
- Date Received
- November 7, 2008
- Date of Event
- October 5, 2008
- Report Date
- November 4, 2008
- Manufacturer
- STERIS MEXICO S. DE R.L. DE C.V.
- Product Code
- FLE
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
A STERIS SERVICE TECHNICIAN VISITED THE HOSPITAL TO INVESTIGATE THIS INCIDENT. THE TECHNICIAN DETERMINED THAT THE OPERATOR DID NOT FOLLOW THE SAFETY INSTRUCTIONS WHICH WARN OF THE BURN HAZARD AND DIRECT OPERATORS TO STEP BACK FROM THE STERILIZER TO MINIMIZE CONTACT WITH THE STEAM VAPOR WHEN OPENING THE UNIT.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THE EMPLOYEE IS FINE AND HAS NO SUSTAINING INJURIES.
Description of Event or Problem · 1
AT THE COMPLETION OF THE STEAM STERILIZER CYCLE, THE OPERATOR OPENED THE UNIT. SOME STEAM WAS DISCHARGED, BUT THE OPERATOR DID NOT WAIT FOR ALL OF THE STEAM TO DISCHARGE. WHILE REACHING INTO THE UNIT, OPERATOR CAME INTO CONTACT WITH THE REMAINING STEAM AND RECEIVED BURNS TO THE HEAD AND FACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EAGLE 3000 STAGE II STERILIZER | STERILIZER | FLE | STERIS MEXICO S. DE R.L. DE C.V. | 1041017 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |