MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for STRYKEFLOW 250-070-500 manufactured by Stryker Endoscopy.
[130039019]
While the nurse was spiking sodium chloride (nacl) bag for suction irrigation, the tubing connecting to the battery pack shot out fluid. It did not contaminate the sterile field, but was very close. During this case, it happened with two irrigators. New irrigators from a different lot number were used without an issue. All of the irrigators with this lot number were pulled from stock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8154531 |
| MDR Report Key | 8154531 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-11-30 |
| Report Date | 2018-12-07 |
| Date Reported to FDA | 2018-12-07 |
| Date Reported to Mfgr | 2018-12-12 |
| Date Added to Maude | 2018-12-12 |
| 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 | STRYKEFLOW |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2018-12-12 |
| Model Number | 250-070-500 |
| Lot Number | 18278FG2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-12-12 |