MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for STRYKEFLOW 0250070520 250-070-520 manufactured by Stryker Endoscopy.
[184265778]
Stryker laparoscopic irrigator was being prepared prior to start of laparoscopic case. When the bag of irrigation was spiked with the battery case/spike, fluid from bag infiltrated the battery compartment and discolored fluid began to run out of the battery compartment and down the external tubing. Leak was identified and item was thrown off the sterile field before any fluid reached the sterile field. Item was not used on patient and fluid did not come in contact with patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859560 |
| MDR Report Key | 9859560 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-02-04 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| 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 | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED |
| Product Code | GCX |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 0250070520 |
| Catalog Number | 250-070-520 |
| Lot Number | 19276FG2 |
| Device Availability | R |
| 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 | 2020-03-20 |