MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for AHTO 0250070600 250-070-600 manufactured by Stryker Corporation.
[182165317]
When we opened the package, the tubing inside was brown instead of clear. We did not place it on the sterile back table. We obtained another irrigation set. There was no patient involvement, and it happened before the patient got into the room and while we were opening up for the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9792382 |
| MDR Report Key | 9792382 |
| Date Received | 2020-03-05 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-31 |
| Report Date | 2020-02-07 |
| Date Reported to FDA | 2020-02-07 |
| Date Reported to Mfgr | 2020-03-05 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | AHTO |
| Generic Name | EVACUATOR, GASTRO-UROLOGY |
| Product Code | KQT |
| Date Received | 2020-03-05 |
| Model Number | 0250070600 |
| Catalog Number | 250-070-600 |
| Lot Number | 18263FG2 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORPORATION |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |