MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for EVOTECH 50014 manufactured by Advanced Sterilization Products Services Inc..
[177800049]
Brand new evotech installed. The spray arm has not been functioning correctly causing the cycles to fail. The issue was intermittent, and the asp technicians have been out several times and have tried several different solutions. Eventually, they told us that it was a manufacturer's defect and they replaced the part altogether. Device is evotech scope washer, catalog #50014, gtin: (b)(4). Manufacturer response for accessories, cleaning, for endoscope, (evotech) (per site reporter). They have offered to trade it out or give us a two-year warranty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9670500 |
| MDR Report Key | 9670500 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-12-21 |
| Report Date | 2020-02-03 |
| Date Reported to FDA | 2020-02-03 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| 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 | 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 | EVOTECH |
| Generic Name | ACCESSORIES, CLEANING, FOR ENDOSCOPE |
| Product Code | FEB |
| Date Received | 2020-02-05 |
| Model Number | 50014 |
| Catalog Number | 50014 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS SERVICES INC. |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |