MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for AHTO 0250070600 250-070-600 manufactured by Stryker Corporation.
[139313823]
A stryker ahto disposable suction/irrigator tube set was leaking from the section that hooks into the irrigation pump. There was no impact to the patient. The tubing was replaced and the procedure was completed as planned. The tubing was saved and will be returned for failure analysis. Manufacturer response for evacuator, gastro-urology, ahto (per site reporter). A complaint form was completed. We intend to return the device for failure analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8435777 |
| MDR Report Key | 8435777 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-01-31 |
| Report Date | 2019-02-15 |
| Date Reported to FDA | 2019-02-15 |
| Date Reported to Mfgr | 2019-03-20 |
| Date Added to Maude | 2019-03-20 |
| 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 | AHTO |
| Generic Name | EVACUATOR, GASTRO-UROLOGY |
| Product Code | KQT |
| Date Received | 2019-03-20 |
| Model Number | 0250070600 |
| Catalog Number | 250-070-600 |
| Lot Number | 18331FG2 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORPORATION |
| Manufacturer Address | 2825 AIRVIEW BOULEVARD PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-20 |