FDA Adverse Event
Malfunction
Summary report: N
STERRAD NX STERILIZER
MDR report key: 1230842
·
Received November 6, 2008
Report
- Report Number
- 2084725-2008-00722
- Event Type
- Malfunction
- Date Received
- November 6, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 8, 2008
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- MLR
- PMA / PMN Number
- K042116
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REFERENCE MDR 2084725-2008-00721.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT TWO UTEROSCOPES HAD WHITE RESIDUE IN THE LUMENS. WITH BOTH SCOPES, THE RESIDUE WAS DISCOVERED DURING A PROCEDURE. IT WAS NOT DETERMINED THAT THERE WAS RESIDUE IN THE CHANNELS UNTIL A GUIDEWIRE WAS PASSED THROUGH THE SCOPE AND THIS WAS DONE WHILE THE SCOPE WAS IN USE WITH THE PT. THE CUSTOMER ALLEGES THAT THERE WERE NO COMPLICATIONS FOLLOWING THE SCOPE USE. THE ASP CUSTOMER CARE REVIEWED THE PROPER CLEANING PROCEDURES WITH THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERRAD NX STERILIZER | STERRAD EQUIPMENT (MLR) | MLR | ADVANCED STERILIZATION PRODUCTS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | SERIAL # UNK| ACMI CIRCON DUR 8 UTEROSCOPE |