MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-04-25 for OLYMPUS RHINO-LARYNGOFIBERSCOPE ENF-P4 manufactured by Olympus Medical Systems Corporation.
[4440114]
Olympus medical systems corp. (omsc) was informed that during nasal endoscopy, the doctor felt that it was difficult to withdraw the subject device from the pt, but the doctor removed it with strong force and consequently, the pt had a slight bloody nose temporarily. After removing it from the pt, the doctor found that a metal part was exposed due to a split on the insertion tube.
Patient Sequence No: 1, Text Type: D, B5
[11878927]
Based on the eval of the subject device by omsc, it was confirmed that the insertion tube was split and there were scratches and indentation marks near the split part. Based on the above result, it is considered that since the user continued to use the device while there were scratches and indentation in the insertion tube, the scratches and indentation grew bigger and it finally tore the insertion tube. It is possible that the scratches and indentation were caused by withdrawing the insertion tube forcibly or hitting the insertion tube with a hard object. The instruction manual of enf-p4 mentions warning and caution for possible mishandling mentioned above. Based on the findings, inappropriate handling by the user could not be ruled out as a contributory factor of the event. 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 | 8010047-2014-00181 |
| MDR Report Key | 3784201 |
| Report Source | 05,07 |
| Date Received | 2014-04-25 |
| Date of Report | 2014-04-01 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-04-01 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2014-05-27 |
| 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 | HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO HACHIOJI-SHI |
| Manufacturer City | TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 26425177 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS RHINO-LARYNGOFIBERSCOPE |
| Generic Name | RHINO-LARYNGOFIBERSCOPE |
| Product Code | CAL |
| Date Received | 2014-04-25 |
| Returned To Mfg | 2014-04-09 |
| Model Number | ENF-P4 |
| 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 SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-25 |