MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for STRYKEFLOW 250-070-500 manufactured by Stryker Instruments.
[185507726]
Suction irrigator requested intraop during lap choley. Sterile suction irrigator set up on field with nacl 0. 9% 1000ml bag. Noted leakage prior to use on floor. When the spike was double checked to make sure it was secure, brown drainage dumped on this writer after lifting the battery pack. There was a significant amount of drainage on floor, bath blanket grabbed to catch remaining drainage from unit. This irrigator was not yet in use on field. It was set up onto field but not used by surgeon. We then pulled unit down & replaced w/stock without issue. The units we opened today now have a paper shield on the bottom of battery pack vs the previous plastic casing. I pulled some off to see if that was the issue/added to bag. I did not open battery case to see if it was a battery leak. The drainage was brown but had dark sediment. Ccs stated we do not use recycled suction irrigators. I made this event patient involved as the risk for infection since it was placed on the sterile field (drainage did not get on field).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897319 |
| MDR Report Key | 9897319 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-17 |
| Report Date | 2020-03-24 |
| Date Reported to FDA | 2020-03-24 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| 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 | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-30 |
| Model Number | 250-070-500 |
| Catalog Number | 250-070-500 |
| Lot Number | 19262FG2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |