MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-04 for OLYMPUS OER-PRO REPROCESSOR manufactured by Olympus Medical System Corporation.
[2650235]
Olympus was informed that two gastroscopes were leaking pink fluid from the auxiliary water ports after having reprocessed in the oer-pro. One of the two gastroscopes was used on a pt. The user facility staff reported that prior to starting the procedure, the light in the room was deactivated. The users reportedly flushed water in the auxiliary water channel and fluid was drained in a piece of gauze and the users proceeded with the procedure. The procedure was said to have been completed with no issue noted, but upon reactivating the light in the procedure room, the users reportedly observed pink fluid on the gauze. The pt was said to have been exposed to an unk pink fluid and the users alleged that the gastroscope may not have been reprocessed properly. The users collected sample of the pink fluid from both of the gastroscopes and requested olympus to conduct further testing of the fluid specifically to test for the presence of blood and alcohol.
Patient Sequence No: 1, Text Type: D, B5
[9846947]
Olympus followed up with the user facility via telephone and in writing to obtain more info regarding the report, but no further info provided. Olympus was not able to obtain the exact serial number of the gastroscope that was used on the pt. The current condition of the pt is unk. The fluid sample and gauze were forwarded to an olympus off-site laboratory for testing. The test results from both the liquid sample and the gauze sample indicated that there was blood in the sample. Based on the glutaraldehyde residual analysis performed the sample showed residual glutaraldehyde on the gauze sample, but the liquid sample did not show any residuals glutaraldehyde. An olympus field service engineer visited the user facility to evaluate the oer-pro and found that one of the yellow port connectors had been removed from the unit by the customer. The fse reinstalled the port connector and tested the unit with the test jig attached to the yellow connector port, but no water was noted to be coming out of the spray hole of the yellow connector. The connector appears to have been clogged with hard water deposits, which likely caused the auxiliary water channel of the gastroscopes to be improperly reprocessed. The yellow connector was replaced, and the unit work appropriately. The fse provided the user facility staff info on the function of the oer-pro including operational manuals. The fse converted the affected unit to use soft water and acecide disinfectant to clear the issue of hard water deposits. This is the first of three reports. Cross reference mfr. Report # 8010047-2012-00139 and 8010047-2012-00140.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00138 |
| MDR Report Key | 2576157 |
| Report Source | 06 |
| Date Received | 2012-05-04 |
| Date of Report | 2012-04-06 |
| Date Mfgr Received | 2012-04-06 |
| Date Added to Maude | 2012-05-31 |
| 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 AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS OER-PRO REPROCESSOR |
| Generic Name | ENDOSCOPE REPROCESSOR |
| Product Code | FAM |
| Date Received | 2012-05-04 |
| Model Number | OER-PRO |
| Catalog Number | OER-PRO |
| Lot Number | NA |
| ID Number | 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 | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-04 |