MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,05 report with the FDA on 2010-01-18 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp.
[1448624]
The customer alleged that they observed cidex opa dripping from the scopes. Subsequently, the customer stated that the observation of the cidex opa residual dripping from the scopes was intermittently observed. The customer stated that they "used the cidex opa test strip to confirm the cidex opa residual in the scope". The cidex solution stained the floor when the devices were hung to dry. The customer stated there have been no reports of adverse effects or injuries involved. An asp field service engineer (fse) went to the facility to assess the unit.
Patient Sequence No: 1, Text Type: D, B5
[1748001]
Patient Sequence No: 1, Text Type: D, B5
[8426226]
Capital equipment at the customer site. The customer reported that regular maintenance for this unit is performed by their own (asp trained) biomedical engineering. The asp fse found the unit functioning properly. The asp fse diagnosed the channel manifold valve not actuating properly. The asp fse replaced the channel manifold valve, the air valve and the one stem adapter and tested the unit. The asp fse performed a cycle with two scopes. The unit conformed to specs.
Patient Sequence No: 1, Text Type: N, H10
[8815223]
Asp investigation summary: the investigation included a device history review, corrective and preventative action plan, service history review, a 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. The hhe reviews each of the causes of this issue as found in the capa and finds the risk to be "low. " a reliability report addresses the channel manifold valve and the air valve, both of which are skinner valves. 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 channel manifold valve and air valve, which are skinner valves were 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. 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 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. The root cause of the problem was identified as a poorly written connection diagram and customers not completing proper flushing of ome scopes. 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 | 2150060-2010-00007 |
| MDR Report Key | 1587796 |
| Report Source | *,05 |
| Date Received | 2010-01-18 |
| Date of Report | 2009-12-30 |
| Date of Event | 2009-12-30 |
| 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 | 2010-01-18 |
| 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 | N |
| 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 | 2010-01-18 |