FDA Adverse Event
Malfunction
Summary report: N
AUTOMATIC ENDOSCOPE REPROCESSOR
MDR report key: 1386894
·
Received February 2, 2009
Report
- Report Number
- 2084725-2009-00050
- Event Type
- Malfunction
- Date Received
- February 2, 2009
- Date of Event
- January 7, 2009
- Report Date
- January 7, 2009
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- NVE
- PMA / PMN Number
- K832458
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPAIRED THE UNIT. IT IS IN OPERATION.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT THE UNIT WAS LEAKING A "GREEN FLUID" WHICH WAS CONFIRMED TO BE CIDEX OPA. THE CUSTOMER STATED THAT NO INJURIES WERE REPORTED FROM THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOMATIC ENDOSCOPE REPROCESSOR | AER EQUIPMENT | NVE | ADVANCED STERILIZATION PRODUCTS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | CIDEX OPA| UNK LOT |