MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-02-08 for OLYMPUS ENDOSCOPES UNK manufactured by Olympus Medical System Corporation.
[17722469]
Olympus was informed of a media report that alleged that a user facility failed to fully disinfect an unidentified model of endoscope that had been used on four previous pts. A pt was said to be undergoing several rounds of testing for sexually transmitted diseases.
Patient Sequence No: 1, Text Type: D, B5
[17984996]
Olympus contacted the user facility to obtain add'l info regarding this report. The user facility reported that they were unsure of which type of endoscopes were involved, however, review of instrument history noted that this user facility had several different types of olympus endoscopes. There were no reports of infections. The user facility stated that another company's tech had inadvertently de-programmed the disinfectant cycle in the facility's automatic endoscope reprocessor (aer). A total of 11 scopes had been reprocessed with the disinfectant cycle turned off. The user facility claimed that their endoscopes underwent an extensive manual reprocessing prior to being placed in the aer. Pts who had received the exam with the device fully disinfected and pts that were examined with the device that had not received the disinfectant cycle were notified and all were requested to have testing performed. It was unk whether there was any cultures performed on the endoscopes. Olympus has requested add'l info regarding this event, however, no further info has been provided. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2011-00020 |
| MDR Report Key | 1994479 |
| Report Source | 07 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-01-12 |
| Date of Event | 2010-09-28 |
| Date Mfgr Received | 2011-01-12 |
| Date Added to Maude | 2011-03-17 |
| 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 | 0 |
| 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 | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ENDOSCOPES |
| Generic Name | ENDOSCOPES |
| Product Code | GDB |
| Date Received | 2011-02-08 |
| Model Number | UNK |
| Catalog Number | UNK |
| 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 | 1. Hospitalization | 2011-02-08 |