MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-06-09 for OLYMPUS TRACHEAL INTUBATION FIBERSCOPE LF-GP UNKNOWN manufactured by Olympus Medical System Corporation.
[2016110]
Olympus was informed that during an unspecified procedure, the tip of the subject device fell into the patient. The tip was reportedly suctioned out from the patient. The patient was reportedly unharmed.
Patient Sequence No: 1, Text Type: D, B5
[9064559]
Olympus followed-up with the user facility via phone and in writing to obtain additional information regarding this report but was not provided any further information. The device referenced in this report was returned to olympus for evaluation. Approximately 30mm of the insertion tube had been torn off from the distal end. Internal elements of the endoscope, including light guide cable in instrument channel, were exposed at the end of the insertion tube that remained connected to the control body. Additionally, the bending section skeleton was noted deformed, and the insertion tube was dented and buckled. Based upon the findings of the investigation, it appears that the distal end of the device was torn from the insertion tube, likely when the endoscope became entrapped on some unknown object and was subjected to extreme physical force. 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 | 8010047-2011-00118 |
| MDR Report Key | 2123529 |
| Report Source | 06,07 |
| Date Received | 2011-06-09 |
| Date of Report | 2011-05-11 |
| Date of Event | 2011-05-11 |
| Date Mfgr Received | 2011-05-11 |
| Date Added to Maude | 2012-03-08 |
| 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 AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM CORPORATION |
| 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 | 2011-06-09 |
| Returned To Mfg | 2011-05-31 |
| Model Number | LF-GP |
| Catalog Number | UNKNOWN |
| Lot Number | NA |
| ID 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 SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-09 |