MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-03-21 for OLYMPUS TRACHEAL INTUBATION FIBERSCOPE LF-2 manufactured by Olympus Medical Systems Corp..
[2576342]
Olympus was informed that the users were not reprocessing the referenced device prior to usage. There was no report of infection or pt cross contamination.
Patient Sequence No: 1, Text Type: D, B5
[9749027]
An olympus endoscopy support specialist had contacted the user facility to arrange an in-service but the user facility reportedly had declined the offer. The olympus endoscopy support specialist is in the process of attempting to f/u with the user facility again, and this report will be supplemented if significant and relevant info becomes available at a later time. No product was returned to olympus for eval. Olympus instruction and/or reprocessing manuals provide detailed info 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 | 8010047-2012-00081 |
| MDR Report Key | 2507509 |
| Report Source | 06,07 |
| Date Received | 2012-03-21 |
| Date of Report | 2012-02-21 |
| Date Mfgr Received | 2012-02-21 |
| Date Added to Maude | 2012-05-24 |
| 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 CORP |
| Manufacturer Street | 2951 ISHIKAWA-CHO HACHIOJI-SHI |
| Manufacturer City | 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 TRACHEAL INTUBATION FIBERSCOPE |
| Generic Name | TRACHEAL INTUBATION FIBERSCOPE |
| Product Code | EQN |
| Date Received | 2012-03-21 |
| Model Number | LF-2 |
| Catalog Number | LF-2 |
| 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 CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-21 |