MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-17 for STRYKEFLOW II SUCTION / IRRIGATOR WITH TIP 250-070-520 manufactured by Stryker Endoscopy.
[108532102]
Patient Sequence No: 1, Text Type: N, H10
[108532103]
After using the device, fluid was noticed leaking into and from battery housing. The irrigation to the patient was clear. Manufacturer response for disposable suction/ irrigator with disposable tip, strykeflow2 (per site reporter). Manufacturer provided rga# for product return evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7521821 |
| MDR Report Key | 7521821 |
| Date Received | 2018-05-17 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-04-05 |
| Report Date | 2018-04-18 |
| Date Reported to FDA | 2018-04-18 |
| Date Reported to Mfgr | 2018-04-18 |
| 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 | 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 | STRYKEFLOW II SUCTION / IRRIGATOR WITH TIP |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2018-05-17 |
| Returned To Mfg | 2018-04-12 |
| Catalog Number | 250-070-520 |
| Lot Number | 18032FG2 |
| ID Number | DISPOSABLE SUCTION/IRRIGATOR |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL CT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-17 |