MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for OLYMPUS BW-412T manufactured by Olympus Medical Systems Corp..
[139550051]
I was notified by a tech that the end of the scope brush fell off during manual cleaning. The missing piece was found in the sink. This incident happened twice.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8443200 |
| MDR Report Key | 8443200 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-03-08 |
| Report Date | 2019-03-12 |
| Date Reported to FDA | 2019-03-12 |
| Date Reported to Mfgr | 2019-03-22 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE |
| Product Code | NWB |
| Date Received | 2019-03-22 |
| Model Number | BW-412T |
| Lot Number | V8926 AND V8907 |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2400 RINGWOOD AVE. SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |