MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for EVIS EXERA III XENON LIGHT SOURCE CLV-190 manufactured by Olympus Medical Systems Corp..
[182998690]
It was reported that during an unspecified procedure to place a stent, the patient? S stomach was perforated. The stent was placed in the duodenum. The user stated that the perforation of the patient's stomach was caused by too much insufflation. The user stated that it was a clinical issue with the patient, not related to the light source or stent used during the procedure. The representative reported that the patient's stomach was repaired and the patient is doing fine. The subject device was not yet been received for evaluation. The cause of the reported event cannot be determined. A supplemental report will be filed if and when the product is returned and investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2020-00368 |
| MDR Report Key | 9816124 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-13 |
| Date Facility Aware | 2020-02-14 |
| Report Date | 2020-02-14 |
| Date Reported to Mfgr | 2020-02-14 |
| Date Added to Maude | 2020-03-11 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA III XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | NWB |
| Date Received | 2020-03-11 |
| Model Number | CLV-190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |