MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for STRYKEFLOW2 250-070-500 manufactured by Stryker.
[102515370]
During laparoscopic cholecystectomy case, the disposable stryker suction irrigator was being used to irrigate and began smoking. The irrigator would not stop suctioning or irrigating when the surgeon stopped pressing the buttons. Product was then removed from the field, and 15 affected lot numbers in inventory were sequestered so they would not be used. Stryker rep was notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075862 |
| MDR Report Key | 7337546 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-03-08 |
| Date Added to Maude | 2018-03-14 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | STRYKEFLOW2 |
| Generic Name | STRYKEFLOW2 |
| Product Code | LJH |
| Date Received | 2018-03-13 |
| Model Number | 250-070-500 |
| Lot Number | 18029FG2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-13 |