MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-03-07 for OLYMPUS TRACHEAL INTUBATION FIBERSCOPE LF-2 manufactured by Olympus Medical Systems Corporation.
[16217375]
The user facility reported that the exterior portion of the insertion tube peeled during an intubation procedure for a laparoscopic pneumectomy, and the peeled pieces fell off into the pt's trachea. The physician removed the peeled pieces from the pt with an unspecified device. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[16430106]
Olympus followed up with the user facility to obtain add'l info about the reported event. The user facility reported that the procedure was interrupted and the pt was discharged. The user reportedly applied polyethylene glycol for lubrication on the insertion tube. The device referenced in this report was returned to olympus for evaluation. The evaluation confirmed the exterior portion of the insertion tube was peeling, and appeared to be consistent with chemical damage. There was residue of polyethylene glycol on the peeled pieces. The insertion tube peeling was attributed to chemical damage from a polyethylene glycol, which is not recommended by olympus. 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 | 8010047-2013-00047 |
| MDR Report Key | 3032156 |
| Report Source | 01,06 |
| Date Received | 2013-03-07 |
| Date of Report | 2013-02-07 |
| Date of Event | 2013-02-07 |
| Date Mfgr Received | 2013-02-07 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 2013-05-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSUMU NISHINA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 1928507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 1928507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS TRACHEAL INTUBATION FIBERSCOPE |
| Generic Name | TRACHEAL INTUBATION SCOPE |
| Product Code | EQN |
| Date Received | 2013-03-07 |
| Returned To Mfg | 2013-02-13 |
| 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 | 2013-03-07 |