MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,05 report with the FDA on 2009-12-04 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp.
[1513523]
The customer alleged the channels were not being air purged. The customer was currently in the middle of a cycle and will call back to troubleshoot. Advanced sterilization products (asp) later contacted the customer, she stated there was a residual drip after the scope was processed in the unit. After the scope is hung dry for several days, a "green crusty" residue appeared on the scope. The customer stated the scope was not used on pts and was reprocessed. Presently, the green residue is still present after the scope is hung dry. When the residue is witnessed, the customer reprocesses the scope prior to use. The customer stated the unit is functioning normally. A service was not requested.
Patient Sequence No: 1, Text Type: D, B5
[21227625]
Asp investigation summary: the investigation included a device history review, a service history review, corrective and preventative action plan, reliability report and health hazard evaluation. The dhr (device history record) for this aer unit was reviewed and it revealed the unit met the manufacturer's specifications at the time of release. Within the past six months ((b)(4) 2010 - (b)(4) 2010), per the account history, this unit has not observed a significant trend of the same staining issue. A capa (corrective and preventative action plan) was opened to address issues of residual fluid in scopes. These were found to be related to poorly written scope connection diagrams and inadequate flushing of scopes. The account history was reviewed and it showed no similar complaints for residual fluid remaining in or outside of the endoscope after the implementation of this capa. A reliability report addresses the channel manifold valve and the air valve, both of which are skinner valves. The causes of the residual fluid in scopes issue as found in the capa were reviewed and found the risk to be "low. " the useful life of the skinner valve assembly is two years or 2000 hours of use. Upon review of this aer unit's service history, it was found that the compressor skinner valve was not replaced between (b)(4) 2008 and (b)(4) 2010. Thus, the ages of these components are greater than two years. Their replacements are considered routine servicing and can be attributed to normal wear and tear of the unit. No further investigation is necessary. The customer subsequently reported the same issue, which was captured under (b)(4) - cidex opa was dripping from the scopes. The asp technical service representative (tsr) informed the customer that this issue might be likely due to their processing methods; however, the customer did not wish to address this concern and requested service. The asp fse (field service engineer) found that the channel manifold valve was not actuating properly. The asp fse replaced the channel manifold valve, the air valve, and a stem adapter. The fse then tested the unit and ran a cycle with two scopes. After the repairs, the unit met specifications. Upon follow-up, the customer stated that residual cidex opa solution intermittently drips from the scopes and stains. The fse and ae (account executive) went through the proper scope connections with the customer. There were no reports of any patient injuries. Asp clinical services reviewed the customer's cleaning processes. Asp clinical services also reviewed and emailed the connector guides for the olympus 160 to the customer and also reviewed endoscope staining and residual fluid post processing with the customer. The customer confirmed that they were using the correct diagrams to hook up the scopes. Cidex opa was staining the large port and the auxiliary water channel. Upon later follow-up, the customer confirmed that the staining issue was resolved, but could not determine why residual disinfectant was no longer observed. A letter was sent to the customer recommending they review copies of the olympus scope connection diagrams for olympus 160s and 180s which can be found on the asp website. A copy of a customer letter addressing staining in general while using cidex opa solution was also sent to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00168 |
| MDR Report Key | 1556459 |
| Report Source | *,05 |
| Date Received | 2009-12-04 |
| Date of Report | 2009-11-05 |
| Date of Event | 2009-11-05 |
| Date Mfgr Received | 2010-12-17 |
| Date Added to Maude | 2011-01-28 |
| 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 DR |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | MINNTECH CORP |
| 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 | 2009-12-04 |
| 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 CORP |
| Manufacturer Address | MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-04 |