MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-01-31 for OLYMPUS TRACHEAL INTUBATION FIBERSCOPE LF-GP manufactured by Olympus Medical Systems Corporation.
[3154305]
Olympus was informed that the referenced device has never been reprocessed in high-level disinfectant. The users reportedly would clean the scope with alcohol only and placed it back into storage after each usage.
Patient Sequence No: 1, Text Type: D, B5
[10500422]
Olympus followed-up with the user facility via phone and in writing to obtain additional information regarding this report with no success. An olympus endoscopy service specialist contacted the customer to schedule an in-service but as to date, there was no response heard. No product was returned to olympus for evaluation. If additional and significant information becomes available at a later time, then this report will be supplemented. Olympus instruction and/or reprocessing manuals provide detailed information on how to reprocess the subject endoscope. The cause of this report appears to be due to user error. 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 | 8010047-2013-00035 |
| MDR Report Key | 2949528 |
| Report Source | 06,07 |
| Date Received | 2013-01-31 |
| Date of Report | 2013-01-03 |
| Date Mfgr Received | 2013-01-03 |
| Date Added to Maude | 2013-02-26 |
| 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 STROMS-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 TRACHEAL INTUBATION FIBERSCOPE |
| Generic Name | FIBERSCOPE |
| Product Code | EQN |
| Date Received | 2013-01-31 |
| Model Number | LF-GP |
| Catalog Number | LF-GP |
| 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 SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-31 |