MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-20 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corporation.
[1251051]
The customer alleged cidex opa solution was dripping from the scope staining the scope cabinet and the basin on the aer. The customer stated dark stains were present. The customer uses the aer unit to process the olympus scopes with model numbers h180al and qh1801al. The customer stated two scopes were processed in the aer simultaneously. The basins were not washed with any type of detergent or cleaning agent. The customer stated the cidex opa solution was clear when it dripped out of the scopes. It turned dark after making contact with the basin and scope cabinet. The customer also stated after less amount of enzol was used, the staining occurred less frequent. No patients were involved. All scopes are reprocessed if staining is witnessed.
Patient Sequence No: 1, Text Type: D, B5
[8301732]
Advanced sterilization products (asp) informed the customer to use proper dilution of enzol and water for pre-cleaning and manual cleaning. Asp also informed the customer to ensure instruments are properly cleaned and rinsed per their cleaning procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00166 |
| MDR Report Key | 1550714 |
| Report Source | 05 |
| Date Received | 2009-11-20 |
| Date of Report | 2009-10-27 |
| Date of Event | 2009-10-27 |
| Date Mfgr Received | 2009-10-27 |
| Date Added to Maude | 2010-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GINNY STAMBERGER |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | MINNTECH CORPORATION |
| Manufacturer Street | 14605 28TH AVE. NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-11-20 |
| Model Number | NA |
| Catalog Number | 20301 |
| Lot Number | NA |
| ID Number | PART #: NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINNTECH CORPORATION |
| Manufacturer Address | MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-20 |