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 |