MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-07 for OLYMPUS TRACHEAL INTUBATION FIBERSCOPE LF-GP manufactured by Olympus Medical System Corp.
[3303590]
Olympus received a medwatch report that stated, "tip of intubating scope missing when removed from pt, seen in bronchus on x-ray. During bronchoscopy attempt to retrieve, pt required cardiopulmonary resuscitation and experienced hypoxia. "
Patient Sequence No: 1, Text Type: D, B5
[10556566]
Olympus followed up with the suer facility regarding this report and was used in intubating the pt prior to a surgical procedure. Upon withdrawal of the subject device from the pt, the user noted that the tip of the subject device was missing. The user was not able to visualize the missing piece in the pt or on the floor. After the surgery an x-ray was performed and a foreign object was noted in the left bronchus of the pt. A pulmonologist was called in the operating room to assist in the retrieval of the foreign object. However, the pulmonologist opted not to retrieve it because the endotracheal tube was too short. The pt was put on a life support after the surgery and reportedly expired after several weeks post procedure. According to the risk manager, the primary cause of death was anoxic brain injury. The subject device was taken out of service and it is not available for evaluation at this time. The exact cause of the user's report could not be conclusively determined at this time. If additional and significant information becomes available at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2013-00074 |
| MDR Report Key | 3001642 |
| Report Source | 06 |
| Date Received | 2013-03-07 |
| Date of Report | 2013-03-05 |
| Date of Event | 2013-01-06 |
| Date Mfgr Received | 2013-03-15 |
| Date Added to Maude | 2013-03-14 |
| 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 | 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 AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM CORP |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, 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 | 2013-03-07 |
| Model Number | LF-GP |
| Catalog Number | LF-GP |
| Lot 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 SYSTEM CORP |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-03-07 |