MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for AHTO 0250070600 250-070-600 manufactured by Stryker Corporation.
[107220389]
Patient Sequence No: 1, Text Type: N, H10
[107220390]
Plugged in suction irrigator and connected tubing set to pump using irrigator lot #18058fg2. Unable to irrigate. Attempted reconnection irrigation pump and tubing, replaced pump and the problem continued. Replaced tubing set with 18064fg2 and worked until near end of case, then set appeared to be occluded (would irrigate but not suction). Ran the lines to pump and suction, surgeons assessed and reconnected their end, i reconnected the tubing set, no visible issues. Changed the tubing set with another set, lot # 18064fg2, suction & irrigation worked and able to finish case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7482701 |
| MDR Report Key | 7482701 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-04-30 |
| Date of Event | 2018-04-26 |
| Report Date | 2018-04-30 |
| Date Reported to FDA | 2018-04-30 |
| Date Reported to Mfgr | 2018-04-30 |
| Date Added to Maude | 2018-05-03 |
| 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 |
| 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 | 2018-05-03 |
| Model Number | 0250070600 |
| Catalog Number | 250-070-600 |
| Lot Number | 18064FG2 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORPORATION |
| Manufacturer Address | 5900 OPTICAL CT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-03 |