MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-04-08 for OLYMPUS TRACHEAL INTUBATION FIBERSCOPE LF-2 manufactured by Olympus Medical Systems Corporation.
[14929153]
The user facility reported that the exterior portion of the insertion tube was peeled during a differential lung ventilation, and the peeled pieces fell off into the endotracheal tube. The physician recovered the peeled pieces and completed the procedure with a similar device.
Patient Sequence No: 1, Text Type: D, B5
[15452564]
Olympus followed up with the user facility to obtain additional information regarding the reported event, and was informed that the users were directly spraying xylocaine on the insertion tube. The user further reported that there was no device fragment identified to have fallen inside the patient. The device reference in this report was returned to olympus for evaluation. The evaluation confirmed that the exterior portion of the insertion tube was peeling, and appeared to be consistent with chemical damage. The insertion tube peeling was attributed to chemical damage caused by the use of xylocaine spray, which is not recommended by olympus. The oem deemed this report closed and no further action required. 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 | 8010047-2011-00077 |
| MDR Report Key | 2058986 |
| Report Source | 01,06 |
| Date Received | 2011-04-08 |
| Date of Report | 2011-03-11 |
| Date of Event | 2011-03-10 |
| Date Mfgr Received | 2011-03-11 |
| Date Added to Maude | 2011-05-10 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| 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 | 2011-04-08 |
| Returned To Mfg | 2011-03-30 |
| Model Number | LF-2 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME TOKYO 163-91 JA 163-91 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-08 |