MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,05 report with the FDA on 2009-10-08 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp.
[1308847]
The customer alleged fluid was dripping from the processed scopes. The issue occurred for two days. The customer stated the scope residual was due to a long auxiliary port used during processing. After changing to a short auxiliary port, the issue was resolved. The customer stated cidex opa and the aer unit did not cause the issue. The residual issue has not resurfaced. No pts were involved. The unit is in full operation.
Patient Sequence No: 1, Text Type: D, B5
[1830939]
Patient Sequence No: 1, Text Type: D, B5
[8938150]
Asp investigation summary: the investigation included a corrective and preventative action plan, a service history review, and health hazard evaluation. A capa (corrective and preventative action plan) was opened to address issues of residual fluid in scopes which were found to be related to poorly written scope connection diagram and customer inadequate flushing of scopes. This account history was reviewed and showed no similar complaints for residual fluid remaining in or outside of the endoscope after the implementation of this capa. The hhe (health hazard evaluation ) reviews each of the causes of the residual fluid in scopes issue as found in the capa and finds the risk to be "low. " the asp fse (field service engineer) found the customer had staining on the towel after manually blowing out the scope. The air flow out of all the channels was 18 psi. The asp fse increased the air flow to 20 psi and the staining resolved. Upon follow-up, the customer stated that the residual cidex opa solution in the scope was due to a long auxiliary port used during processing. After changing to a short auxiliary port, the issue was resolved. The customer stated that the cidex opa solution and the aer unit did not cause the issue. The root cause of the problem was identified as a poorly written scope connection diagram and customers not completing proper flushing of some scopes. Upon follow-up, the customer confirmed that the issue ahs bit recurred and that the unit was in full operation. A letter was sent to the customer recommending they review the olympus scope 180 connection diagrams which can also be found on the asp website.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00152 |
| MDR Report Key | 1510808 |
| Report Source | *,05 |
| Date Received | 2009-10-08 |
| Date of Report | 2009-09-10 |
| Date of Event | 2009-09-10 |
| 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 | 2009-10-08 |
| 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 | 2009-10-08 |