MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2011-01-05 for OLYMPUS ENDOSCOPES UNK manufactured by Olympus Medical Systems Corporation.
[1781826]
Olympus was informed that an employee allegedly sustained unspecified permanent bodily injuries due to repeated exposure to another company's high-level disinfectant while reprocessing olympus endoscopes.
Patient Sequence No: 1, Text Type: D, B5
[8818257]
The reporter alleged that olympus negligently designed the unspecified endoscope and negligently specified the cleaning process of the subject device using another company's high-level disinfectant. The reporter also claimed that olympus negligently instructed user facility personnel in how to clean the subject scopes using the other company's high-level disinfectant and did not sufficiently warn users of the dangers of the cleaning process. The reporter also claimed that olympus negligently held the cleaning process for the endoscope as a safe process, when it was not. No devices was returned to olympus for evaluation, and no specific info regarding the model or serial numbers of endoscopes were provided. The exact cause of the user's claim could not be conclusively determined. Olympus instruction manuals advise users to use appropriate personal protective equipment, and to follow disinfectant manufacturer's instructions when reprocessing endoscopes. 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 | 8010047-2010-00266 |
| MDR Report Key | 1962512 |
| Report Source | 00,04 |
| Date Received | 2011-01-05 |
| Date of Report | 2010-12-07 |
| Date of Event | 2001-08-01 |
| Date Mfgr Received | 2010-12-07 |
| Date Added to Maude | 2011-01-21 |
| 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 SYSTEMS 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 ENDOSCOPES |
| Generic Name | ENDOSCOPES |
| Product Code | GCQ |
| Date Received | 2011-01-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-05 |