FDA Adverse Event
Malfunction
Summary report: N
STERIS SYSTEM 1
MDR report key: 548903
·
Received April 8, 2004
Report
- Report Number
- 1527821-2004-00004
- Event Type
- Malfunction
- Date Received
- April 8, 2004
- Date of Event
- March 9, 2004
- Report Date
- March 9, 2004
- Manufacturer
- STERIS CORPORATION/MENTOR HOPKINS
- Product Code
- FLE
- Removal / Correction Number
- 1527821-03/19/04-001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FACILITY HAD TWO STERIS QPC1680 QUICK CONNECT FLOW UNITS USED FOR PROCESSING SCOPES IN THE STERIS SYSTEM 1 PROCESSOR. ACCORDING TO THE TECHNICIAN, THE CUSTOMER OBTAINED THE QUICK CONNECTS FROM THE PENTAX REPRESENTATIVE. THE TECHNICIAN OBSERVED THAT THE NUMBER 9 LABELED ADAPTERS FOR THE UNITS APPEARED DIFFERENT. THE CUSTOMER RETURNED ONE OF THE QPC 1680 UNITS TO STERIS FOR EVALUATION. INSPECTION AT STERIS REVEALED THAT THE NUMBER 9 ADAPTOR ON THE RETURNED UNIT MAY HAVE BEEN CONFIGURED UPSIDE DOWN BY THE THIRD PARTY MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERIS SYSTEM 1 | STERILE PROCESSING SYSTEM | FLE | STERIS CORPORATION/MENTOR HOPKINS | QPC 1680 | 2925196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |