MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2007-10-12 for OLYMPUS CF-Q180AL manufactured by Olympus Medical Systems Corporation.
[20239256]
An olympus endoscopy support specialist (ess) visited the user facility to conduct a quick track review of the facility's reprocessing steps. During the visit, the ess observed that the user facility was not reprocessing the auxiliary water inlet on their endoscopes. The ess reported that the facility's staff had never flushed the auxiliary water inlet of their endoscopes during manual cleaning, as they were not instructed to do so. In addition, the ess discovered that the facility did not have the correct tubing to reprocess the auxiliary water inlet or the elevator channel. The facility's management was immediately informed about this observation and both the ess and the facility's management rep decided to take all the endoscopes with an auxiliary water inlet out of circulation. There was no pt infection associated with this report. On the same day, the ess and an olympus field service engineer (fse) provided the correct tubing for the automated endoscope reprocessor used in the facility and trained the facility's staff. An in-service was also provided by the ess on the same day to address the issue.
Patient Sequence No: 1, Text Type: D, B5
[20544659]
The device referenced in this report was not returned to olympus for investigation. However, an olympus' microbiologist contacted the facility regarding the report and according to the practice administrator in the facility, they have been manually flushing the endoscopes, but the facility's administrator admitted that they failed to hook up the hose or tubing from the automated endoscope reprocessor to the channels of the endoscope. The user facility also reported that they have conducted some culture tests on their endoscopes and the test results were negative. This report is being filed as an mdr in apparent user error to follow olympus' recommended reprocessing instructions. The device instruction manual states that, "all channels of the endoscope, including the auxiliary water channel, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous pt procedure. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the pt and/or operators performing next procedure with the endoscope. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00148 |
| MDR Report Key | 926531 |
| Report Source | 00,05,06 |
| Date Received | 2007-10-12 |
| Date of Report | 2007-09-16 |
| Date of Event | 2007-09-14 |
| Date Added to Maude | 2007-12-04 |
| 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 | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU-KU 1-CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | COLONSCOPE |
| Product Code | FTJ |
| Date Received | 2007-10-12 |
| Model Number | CF-Q180AL |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 912388 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-12 |