MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for STRYKERFLOW 2 250-070-0500 manufactured by Stryker Corporation.
[178565420]
Stryker suction irrigator for laparoscopic case failed. Significant delay in replacement with patient bleeding during laparoscopic case. Had to convert to open technique. Per the operating room report: active bleeding was found along the left uterine artery. Irrigation failed to visualize bleeding due to equipment malfunction. Attempts were made to de-clot instrument, increase suction and replace tubing. However, the mechanical failure continued. Patient remained stable with vital signs throughout this process. Bleeding continued despite attempts to cauterize with ligasure. Due to continued bleeding and failure of equipment to gain visualization, decision made to convert to open technique.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9693671 |
| MDR Report Key | 9693671 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-11-21 |
| Report Date | 2020-01-07 |
| Date Reported to FDA | 2020-01-07 |
| Date Reported to Mfgr | 2020-02-11 |
| Date Added to Maude | 2020-02-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | STRYKERFLOW 2 |
| Generic Name | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED |
| Product Code | GCX |
| Date Received | 2020-02-11 |
| Catalog Number | 250-070-0500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-11 |