MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-17 for STRYKER STRYKEFLOW II SUCTION / IRRIGATOR 250-070-500 manufactured by Stryker Endoscopy.
[108531757]
Patient Sequence No: 1, Text Type: N, H10
[108531758]
Suction irrigator was leaking during the case. This has occurred maybe only 2 times in the past few months. However, we only started using the stryker irrigator recently because the product was unavailable. When we were using it on a regular basis, it seemed to occur rather frequently but only on bariatric cases with the long suction tip. The rep told us that the long tip was disposable after 10 uses. No one was ever able to find the ifu that stated this fact. The rep also suggested not placing full pressure on the button when irrigating. This message was given to the rnfa who seemed to have the most issues. At the point in the surgery when the irrigator is used, she is pressing very gently on the button so this was not the cause. Manufacturer response for suction irrigator, strykeflow (per site reporter).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7521745 |
| MDR Report Key | 7521745 |
| Date Received | 2018-05-17 |
| Date of Report | 2018-05-03 |
| Date of Event | 2018-04-19 |
| Report Date | 2018-05-03 |
| Date Reported to FDA | 2018-05-03 |
| Date Reported to Mfgr | 2018-05-03 |
| Date Added to Maude | 2018-05-17 |
| 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 |
| 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 | STRYKER STRYKEFLOW II SUCTION / IRRIGATOR |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2018-05-17 |
| Model Number | 250-070-500 |
| Catalog Number | 250-070-500 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-17 |